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PowerPICC® SV Catheter 3274355Recalls & reported problems

Bard Access Systems, Inc. · PPICC SV 4Fr DL IR w/Nit · Class 2 · Implant

All models of PowerPICC SV Catheter (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Bard PowerPICC catheter is a small, long-term central line placed through a vein in the arm. Most of the 51 reports describe leaking or cracking, either at the hub where the line splits into two lumens or along the tubing, and a few describe parts breaking or coming loose; some lines had to be replaced early. Two injuries were reported and no deaths. There are no recalls naming this device. Reports fell sharply, from 20 in the prior 12 months to 1 in the last 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
51
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00801741027864), received between Apr 10, 2017 and Feb 19, 2026 — classified as 2 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (38 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 6 reportsApr 2025: 2 reportsMay 2025: 1 reportsJun 2025: 4 reportsJul 2025: 3 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak38
  • Break9
  • Defective Device2
  • Detachment Of Device Component2
  • Fracture2
  • Crack1
  • Device Dislodged or Dislocated1
  • Difficult or Delayed Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions22
  • No Consequences Or Impact To Patient16
  • No Known Impact Or Consequence To Patient6
  • Hemorrhage/Blood Loss/Bleeding3
  • Insufficient Information1
  • No Information1
  • Pressure Sore/Ulcer1
  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 19, 2026Fluid/Blood Leak

    IT WAS REPORTED VIA MEDWATCH THAT WHILE FLUSHING LUMEN AND ATTEMPTING TO DRAW LABS NOTICED LEAKING FROM THE CATHETER. BLOOD DRIPPING FROM EXTENSION LEG WHERE CLEAR EXTENSION LEG OF PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) MEETS PLASTIC HUB THAT NEEDLELESS CONNECTOR ATTACHES TO. PATIENT WITH 4FR DUAL LUMEN BARD SMALL VEIN POWERPICC. CRACK WAS NOTED WHERE LEAKING WAS DESCRIBED. EXTENSION LEG CLEANED THOROUGHLY WITH ALCOHOL, WRAPPED IN GAUZE WITH ANTISEPTIC AGENT AT BREAK SITE. PICC CLAMP ENGAGED ABOVE BREAK AS WELL AS GREEN HEMOSTAT OVER GAUZE. CONSULT PLACED FOR PICC REWIRE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24388487 ↗
  • MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED SALINE LOCKED LUMEN OF PICC LINE CRACKED AT WHERE HUB AND LUMEN TUBING MEET ON RED LUMEN. NURSES RESPONDED APPROPRIATELY TO CRACKED LUMEN AND IR CASE WAS SCHEDULED TIMELY. ADDITIONAL PROCEDURE, NO OTHER HARM TO PATIENT. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23352117 ↗
  • MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED PICC LASTS ABOUT 1 TO 1 1/2 MONTHS BEFORE LUMEN CRACKS. PATIENT HAS BEEN LONG STANDING 1A STATUS FOR CARDIAC TRANSPLANT. EJECTION FRACTION IS TOO LOW FOR HER TO BE SAFE TO RECEIVE A SURGICALLY PLACED LINE (BROVIAC VS PORT). NURSES RESPONDED APPROPRIATELY TO CRACKED LUMEN AND IR CASE WAS SCHEDULED TIMELY. ADDITIONAL PROCEDURE BUT NO OTHER HARM TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23351480 ↗
  • MalfunctionJul 28, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

    IT WAS REPORTED, PICC HUB BROKE/CRACKED 2 WEEKS AFTER PLACEMENT AND REQUIRED REPLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22632113 ↗
  • InjuryJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED PATIENT ARRIVED TO UNIT FROM ED. ON ADMISSION, THE BEDSIDE NURSE NOTICED THE BURN NETTING OVER THE PATIENTS PICC LINE WAS SATURATED WITH BLOOD. UPON INSPECTION OF PICC DRESSING, THE EDGES WERE NONOCCLUSIVE AND THE ENTIRE DRESSING WAS SATURATED WITH BLOOD. PER REPORT FROM ED RN DRESSING HAD SMALL AMOUNT OF BLOOD, BUT PER CHARTING MULTIPLE STAFF NOTED DRESSING WAS SOILED AND NEED TO BE CHANGED. I ALSO NOTICED BOTH THE DISTAL AND PROXIMAL LUMEN HAD BLOOD IN THE TUBING. THE PROXIMAL LUMEN STILL HAD HOME IV INFUSION LINE ATTACHED. WHEN ASKED, MOTHER STATED THE DRESSING HAS LOOKED THAT WAY SINCE ARRIVING TO ED (6/29/1529). PHOTOS WERE TAKEN UPON ADMISSION AND UPLOADED TO THE CHART. MD NOTIFIED OF PICC LINE STATUS, AND FOR PLAN CLARIFICATION. PER MD, WAS INSTRUCTED TO COMPLETE A DRESSING CHANGE, AND TO ACCESS AND HEP LOCK THE DISTAL LUMEN IF NOT OCCLUDED BY THROMBUS THAT WAS NOTED ON ULTRASOUND IN ED. DRESSING WAS CHANGED, DISTAL LUMEN FLUSHED, AND DRESSING WAS IMMEDIATELY SATURATED BY BLOOD AND SALINE FROM FLUSH. DISTAL LUMEN LEAKING TOWARDS INSERTION SITE AND LEAKING TOWARDS THE MIDDLE OF THE TUBING. UNABLE TO HEP LOCK DUE TO MED LEAKING OUT OF THE LINE. MD NOTIFIED, WAS

    Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

    MAUDE report 22527301 ↗
  • MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS PLACED ON (B)(6) 2025; DISCHARGED HOME WITH PICC. ON (B)(6) 2025 PATIENT PRESENTED TO THE ED FOR EVALUATION OF PICC. DURING DRESSING CHANGE AT HOME THAT MORNING, THE PICC WAS NOTED TO BE LEAKING. THE VASCULAR ACCESS TEAM WAS CONSULTED FOR LEAKING AT THE INSERTION SITE. CHEST X-RAY CONFIRMED NO CHANGE IN CATHETER TIP POSITION TERMINATING IN THE SVC. UPON ASSESSMENT DRESSING WAS INTACT WITH ¿MUSHROOMING¿ OF BIOPATCH INDICATING LEAKAGE AT SITE. PT DENIED PAIN TO SITE. WHITE PORT WAS ACCESSED, BLOOD RETURN NOTED. WHEN FLUSHED NORMAL SALINE IMMEDIATELY FLOWED OUT FROM INSERTION SITE, SUSPICIOUS FOR PICC FRACTURE. NEW 4 FR DUAL LUMEN PICC WAS PLACED IN THE LEFT UPPER ARM, CEPHALIC VEIN, WHILE PATIENT WAS IN THE EMERGENCY DEPARTMENT. PREVIOUS PICC WAS REMOVED. NO FURTHER INFORMATION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22527106 ↗
  • MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THIS IS THE SECOND TIME PATIENT HAD A PICC LEAK. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 22136245 ↗
  • InjuryJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED (B)(6) 2025 AT 1:37 AM: WHEN DOING CAP AND LINE CHANGE, THE RN ATTACHED THE NEW CAP TO THE WHITE LUMEN OF THE PICC LINE. AFTER ATTACHING THE CAP, THE RN FLUSHED THE LINE WITH NORMAL SALINE AND DREW BACK ON THE LINE TO CHECK FOR BLOOD RETURN. WHILE DOING THIS, THE RN NOTICED THAT THERE WAS FLUID LEAKING FROM THE WHITE LUMEN. THE RN ASSESSED THE LINE AND DISCONNECTED THE CAP AND ATTACHED A NEW ONE. THE RN FLUSHED THE LINE AGAIN WITH THE NEW CAP AND NOTED LEAKING AGAIN. PICC WAS IN PLACE FOR 50 DAYS. ACTIVE PEDIATRIC PATIENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: PATIENT HAD TO RETURN THE CATH LAB AND REQUIRED ANESTHESIA FOR A LINE CHANGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22136200 ↗
  • MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED, PICC CRACKED NEAR HUB. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22132943 ↗
  • MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA MEDWATCH THAT 4 FRENCH BARD IN PLACE FOR 32 DAYS BEFORE LEAKING NOTING ON DRESSING CHANGE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22129043 ↗
  • MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT LEAKAGE WAS HAPPENING WHEN FLUSHING THE CATHETER AT THE INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21973736 ↗
  • MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY MEDWATCH IVT (INTRA VENOUS THERAPY) PERFORMED CENTRAL LINE ROUNDS. PT'S PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) NEEDED FLUSHED; LEAKING WAS NOTED UNDER THE DRESSING AND AIR IN LINE WHEN ASPIRATING FOR BLOOD. WHEN THE DRESSING WAS REMOVED, FLUID WAS COMING OUT OF THE HUB OF THE PICC WHEN FLUSHING. CHRU (CLINICAL HIV RESEARCH UNIT) DR NOTIFIED WHO ORDERED REMOVAL OF THE PICC. IVT REMOVED PICC PER ORDER. THERE WAS ALSO CREATION OF A PRESSURE WOUND IN THE ARM DUE TO THE HUBBING OF THE PICC INTO THE INSERTION SITE. ANY ADDITIONAL KNOWN PRODUCT DETAILS: BREAK IN LINE WHERE CATHETER MEETS HUB. PICC WAS INSERTED (B)(6) 2024 AND REMOVED (B)(6) 2024. PICC SECURED WITH STATLOCK. PRESSURE WOUND DISCOVERED AFTER PICC WAS REMOVED AND NO TREATMENT WAS NEEDED. THE EVENT DID NOT CAUSE A DELAY IN TREATMENT. A NEW CATHETER WAS INSERTED. THERE WAS NO ADVERSE PATIENT OUTCOMES.

    Patient problems: Pressure Sore/Ulcer

    MAUDE report 21904679 ↗
  • MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED SMALL VEIN PICCS BROKE/CRACKED NEAR THE HUB, CAUSING FOR THE HOSPITAL TO HAVE TO DO AN OVER THE WIRE TRANSFER OF A NEW PICC LINE FOR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21779503 ↗
  • MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER PATIENT WAS SITTING IN HOSPITAL BED WHEN SHE SAW BLOOD BACKED UP IN THE RED LUMEN. NURSE HAPPENED TO BE IN THE ROOM AND SAW BLOOD BEADING UP OUTSIDE THE TUBING, IT APPEARED THAT THERE WAS A SPLIT IN THE TUBING RIGHT BEFORE IT ENTERS INTO THE WHITE PORTION OF THE PICC. PATIENT IS REPORTED TO BE ACTIVE BUT NOT OVERLY ACTIVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21733150 ↗
  • MalfunctionMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY MEDWATCH CALLED TO BEDSIDE BY IVT RN DUE TO LEAKING NOTED AT INSERTION SITE. UPON ASSESSMENT OF LINE WITH DRESSING ON, SIGNIFICANT LEAKING COMING FROM INSERTION SITE WHEN FLUSHED. DRESSING TAKEN DOWN, STATLOCK REMOVED, AND SITE CLEANSED. CATHETER ORIGINALLY PLACED AT LEVEL OF HUB, CATHETER RETRACTED 2CM TO REVEAL CATHETER BREAK SITE. CATHETER WITH VISIBLE BREAK NEAR 0CM MARKING ON CATHETER. CATHETER THEN REMOVED AN ADDITIONAL 5CM TO ACCOMMODATE PLACING CLAMP ABOVE BREAK SITE. BETADINE GAUZE AND STERILE GAUZE PLACED ABOVE BREAK WITH NON-SERRATED CLAMP. SITE DRESSED WITH OCCLUSIVE DRESSING AND BIOPATCH. HUB SECURED EXTERNAL TO DRESSING, PICU ATTENDING MD IMMEDIATELY NOTIFIED, PLANNING TO PLACE ORDER FOR IR CONSULT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21719484 ↗
  • MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY MEDWATCH, PICC DRESSING STARTING TO LIFT BY BOTTOM OF PANTS, SO CALLED IV TEAM TO CHANGE IT. WHEN THEY CAME TO CHANGE IT, NOTICED LEAKING FROM PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) ONCE SITE WAS WIPED. FLUSHED PICC TO CONFIRM LEAK BY HUB. IV TEAM OBTAINED A PIV FOR DRIPS AND PCAS TO GO THROUGH AND CLAMPED PICC AND WRAPPED IT IN BETADINE AND GAUZE AFTER CLEANING. PER DOCUMENTATION AND REPORT, THERE HAD BEEN SOME BLEEDING AND POTENTIAL LEAKING ON (B)(6) WITH LAST DRESSING CHANGE, BUT THERE WAS DETERMINED NOT TO BE A LEAK AT THAT TIME AND THE PICC WAS DRESSED AS NORMAL. THE SITE WAS CLEAN, DRY, AND INTACT FOR SHIFT OF (B)(6) 2025 UP UNTIL REDRESSING WHEN CURRENT NURSE WAS WORKING, AND PATIENT WAS ADEQUATELY SEDATED WITH (PATIENT-CONTROLLED ANALGESIA) PCA'S GOING THROUGH LINE. NNP (NEONATAL NURSE PRACTITIONER) CALLED, WHO CALLED IR (INTERVENTIONAL RADIOLOGY), AND PICC LINE WAS REWIRED WITHOUT INCIDENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 21713573 ↗
  • MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA MEDWATCH, "IV TEAM CALLED TO ASSESS PICC LINE. WHITE LUMEN FOUND WITH CRACK WHERE PORTION OF WHITE LEG MEETS WHITE PORTION THAT NEEDLELESS CONNECTOR ATTACHES TO. THIS LEG OF THE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS CLAMPED AND BETADINE GAUZE WAS WRAPPED AROUND THE BREAK. MD AWARE AND ADVISED TO CONSULT IR (INTERVENTIONAL RADIOLOGY) TO COORDINATE WITH PT'S ALREADY SCHEDULED OPERATING ROOM PROCEDURE TOMORROW." ADDITIONAL INFORMATION RECEIVED 3/24/2025: IT WAS REPORTED LINE LAST REWIRED NEW ON (B)(6) 2025: CATHETER TYPE: 4 FR, 2 LUMEN CATHETER, 19 CM IN LENGTH, PICC LINE, POWER INJECTABLE. BREAK IDENTIFIED ON (B)(6) 2025. DRESSING APPLIED: OCCLUSIVE DRESSING APPLIED, PICC SUTURED TO SKIN TO AVOID ACCIDENTAL DISLODGMENT. THE LINE IS SUTURED WITH 0.5 CM EXTERNAL LENGTH, AND A 3M CHG OCCLUSIVE DRESSING WAS APPLIED OVER THE SITE. THE LINE WAS REWIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21693255 ↗
  • MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED 4 OCCURRENCES OF PICC LINE FRACTURES, ALL WHERE THE CATHETER MEETS THE HUB. THESE PICCS WERE ALL PLACED IN INTERVENTIONAL RADIOLOGY, AND THE FRACTURES WERE NOTICED DURING THE ROUTINE DRESSING CHANGES THAT WERE PERFORMED BY THE VASCULAR ACCESS TEAM. BLOOD WAS LEAKING FROM THE HUB WHICH HELPED THEM IDENTIFY THE FRACTURE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL FOUR OCCURRENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21548553 ↗
  • MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER, PEDIATRIC PATIENT PICC LINE FRACTURED. PICC WAS PLACED IN INTERVENTIONAL RADIOLOGY, AND WAS NOTICED DURING THE ROUTINE DRESSING CHANGE PERFORMED BY VASCULAR ACCESS TEAM. BLOOD WAS LEAKING FROM THE HUB. A NEW PICC WAS PLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21528623 ↗
  • MalfunctionJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY MEDWATCH AT 0600 REGISTERED NURSE GETTING AM LABS OUT OF LEFT ARM SL PICC. REGISTERED NURSE FLUSHING RED LUMEN MET RESISTANCE DUE TO PATIENT BENDING ARM, THEN REGISTERED NURSE FELT LINE BREAK WITH THE FLUSH AND PICC STARTED LEAKING BLOOD AT THE SITE. REGISTERED NURSE APPLIED PRESSURE AT THE SITE. REGISTERED NURSE CALLED IV TEAM, AND APPLIED PRESSURE DRESSING. IV TEAM AT BEDSIDE AT @0630. IT SEEMS LIKE IT BROKE SPONTANEOUS DURING ROUTING FLUSHING WITH AN APPROPRIATELY SIZED SYRINGE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21175899 ↗
  • MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED PATIENT BEGAN HAVING LEAKING OF CLEAR FLUID FROM STERNUM ON SUNDAY NIGHT PER REPORT. DRESSINGS WERE NEEDING TO BE CHANGED Q2-6 HOURS BECAUSE THEY WERE BECOMING SATURATED. IT WAS THOUGHT TO POTENTIALLY BE PERITONEAL FLUID COMING UP THROUGH THE DIAPHRAGM PER CVS, AND BEDSIDE WAS TOLD BY STAFF MD TO ELEVATE PATIENT TO SEE IF GRAVITY ASSISTED IN DECREASING THE AMOUNT OF DRAINAGE. IT WAS ALSO SPECULATED BY MD WHETHER OR NOT IT WAS JP FLUID AND TO STRIP THE CHEST TUBES REALLY WELL. A PICO DRESSING WAS APPLIED BY CVS ON TUESDAY NOV 5 AT APPROX 1400. BY 1600 THERE WAS AN AREA OF DRAINAGE THE APPROXIMATE SIZE OF A TOONIE. BY 1900 50% OF THE PICO DRESSING WAS SATURATED. BY THE TIME I CAME BACK THE NEXT MORNING THE DRESSING WAS FULLY SATURATED AND HAD BEEN LEAKING OUT OF DRESSING AND SOAKING THE PATIENT'S BED. ON ROUNDS SAID I WAS CONCERNED ABOUT THE STATUS OF THE PATIENT'S RA LINE BECAUSE THE FLUID COMING OUT FROM THE STERNAL WOUND WAS CLEAR, NOT YELLOW LIKE PD FLUID, OR SEROSANG LIKE JP FLUID, AND THE STERNAL WOUND WAS OTHERWISE INTACT. ALL MEDICATIONS WERE MOVED FROM THE RA LINE TO THE PICC LINE. CVL CHASERS WERE RUN AT THE MINIMUM RATE REQUIRED TO KEEP THE RA LINE FROM CLO

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 20899377 ↗
  • MalfunctionOct 27, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER THAT PICC FOUND "BROKEN." ADDITIONAL INFORMATION RECEIVED ON 23-OCT-2023 THE EVENT DID DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT. I¿M UNSURE IF THIS IS THE SPECIFIC BROKEN LINE MENTIONED IN THE INITIAL REPORT. PATIENT UNDERWENT A LINE REPLACEMENT. THE PICC BREAK WAS EXTERNAL, NO PIECES RETAINED IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18024162 ↗
  • MalfunctionMay 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED, "CALLER STATES HER DAUGHTER HAD THIS PICC FOR ABOUT FOUR DAYS THEN IT STARTED LEAKING AND HAD TO BE REMOVED. CALLER STATES AFTER IT WAS REMOVED HER DAUGHTER HAD AN ALLERGIC REACTION TO THE CATHETER. CALLER STATES HER DAUGHTER EXPERIENCED PUFFINESS AND SWELLING. CALLER STATES HER DAUGHTER IS AT HOME, DOING WELL AND TAKING BENADRYL."

    Patient problems: Swelling/ Edema

    MAUDE report 16897678 ↗
  • MalfunctionApr 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE CUSTOMER IS HAVING AN ISSUE WITH ITEM 3274355. PER THE RN, BLOOD NOTED TO BE LEAKING FROM THE CATHETER RIGHT WHERE IT MEETS THE SECUREMENT WINGS. CLEAR AND OBVIOUS LEAK OBSERVED. ADDITIONAL INFORMATION: THE EVENT DID NOT OCCUR DURING AN URGENT OR LIFE-THREATENING MEDICAL SITUATION. TPN INFUSION WAS INTERRUPTED BUT NO ADVERSE OUTCOME WAS REPORTED. THE CATHETER WAS SECURED WITH STATLOCK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16820163 ↗
  • MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED "PATIENT CAME TO CLINIC AND ¿WAS BLEEDING FROM THE PICC¿. PER PARENT-RED LUMEN NOT WORKING. ON ASSESSMENT- THE RED LUMEN IS CRACKED AT THE CONNECTION OF THE TUBING TO THE RED HUB. THE LINE WAS OPEN, BUT ABLE TO SECURE WITH CLAMP ABOVE THE BREAK. PATIENT¿S MOM NOTED THE RED. IT WAS STATED THAT THE LINE WAS REMOVED AND REPLACED."

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 12862762 ↗

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