PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1295118Recalls & reported problems
Bard Access Systems, Inc. · PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 5F Basic Tray with Microintroducer · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPICC SOLO2 catheter is a long-term intravenous catheter with a tip-positioning system. Reports mostly describe fluid or blood leaks, material changing shape or fraying, and problems flushing or staying in place; another report mentions a broken introducer piece retrieved from a patient. There are 24 reports, including 5 injuries, 19 malfunctions, and no deaths. No recalls name this device.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741034633), received between Sep 28, 2017 and Mar 3, 2026 — classified as 5 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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
Most reported problems
Device problems
- Fluid/Blood Leak7
- Material Deformation5
- Material Frayed3
- Device Dislodged or Dislocated2
- Product Quality Problem2
- Adverse Event Without Identified Device or Use Problem1
- Backflow1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- Arrhythmia1
- Confusion/ Disorientation1
- High Blood Pressure/ Hypertension1
- Increased Level of Consciousness1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Product Quality Problem; Material Deformation
IT WAS REPORTED DURING INSERTION OF A PICC LINE, INSERTER FLUSHED THE LINE, MET NO RESISTANCE. UPON SECOND CHECK, FLUSHED THE LINE AGAIN AND FELT SLIGHT RESISTANCE, AND THEN A POP AND RELEASE, THEN THE SALINE SPRAYED BACK OUT OF THE RUBBER SEAL OF THE STYLET ONTO THE INSERTER. STYLET WAS IMMEDIATELY REMOVED. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494865 ↗MalfunctionJan 15, 2026Crack
ADDITIONAL INFORMATION REVIEWED: NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085931 ↗MalfunctionSep 11, 2025Product Quality Problem; Defective Component; Product Quality Problem; Defective Component
ADDITIONAL INFORMATION RECEIVED 19-SEP. THERE WAS NO PATIENT HARM. IT WAS THE LAST FLUSH OF THE INSERT. THE STERILE SALINE SPRAYED BACK OUT TOWARDS THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026322 ↗InjuryJul 15, 2025Material Frayed; Migration or Expulsion of Device; Material Frayed; Migration or Expulsion of Device
IT WAS REPORTED, PATIENT ADMITTED 23 DAYS AGO HAD A CENTRAL JUGULAR CATHETER WITH NO SIGNS OF INFLAMMATION, ON ANTIBIOTICS. AT THE REQUEST OF THE INFECTIOUS DISEASE SPECIALIST, A CATHETER REPLACEMENT WAS REQUESTED YESTERDAY AFTERNOON. AN UNSUCCESSFUL ATTEMPT WAS MADE BY A NURSE, DOCTOR, AND NURSING TECHNICIAN THROUGHOUT THE PROCEDURE, AND THE MOTHER WAS CONSULTED AT THE END. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN IN THE LIMB, MAINLY AT THE PUNCTURE SITE, AND A WARM COMPRESS WAS APPLIED. THIS MORNING, THE PAIN PERSISTED, AND THE PEDIATRIC SURGEON REQUESTED A CHEST CT SCAN TO EXAMINE THE LUNG AFTER REMOVAL OF THE DRAIN, WITH A CENTRAL CATHETER REPLACEMENT SCHEDULED IN THE OPERATING ROOM. THE CT SCAN SHOWED AN OBJECT IN THE MSD, DESCRIBED AS A CATHETER, AND A REVIEW OF THE IMAGE AND REPORT WAS REQUESTED, WHICH SUGGESTED THAT IT WAS THE GUIDE WIRE, SINCE THE PICC HAD NOT BEEN INSERTED. THE NURSE AND DOCTOR REPORTED THAT THE GUIDE WIRE AND CATHETER HAD NOT PROGRESSED. THEY STATED THAT THEY HAD DISCARDED THE GUIDE WIRE, BUT IT WAS STILL INSIDE THE PATIENT. THE PATIENT RETURNED TO THE OPERATING ROOM AT AROUND 5 P.M., AND THE GUIDE WIRE WAS REMOVED, MEASURING 50 CM, BY PUNCTUR
Patient problems: Foreign Body In Patient
MAUDE report 22512116 ↗MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FLUSHING PURPLE LUMEN, BUBBLE OBSERVED IN RED LUMEN TO BE MOVING IN RESPONSE TO FLUSHING IN NEIGHBORING LUMEN. STOPPED ALL USAGE OF PICC. MD AUTHORIZED STOPPING IV ANTIBIOTICS. PICC WAS REMOVED. NO HARM WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621866 ↗InjuryOct 23, 2024Material Deformation; Material Deformation
IT WAS REPORTED BY CUSTOMER THAT THE MICRO INTRODUCER BROKE AND A PIECE GOT STUCK IN A PATIENT. CLINICIAN WAS ABLE TO RETRIEVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 20516445 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STATLOCK CLIP CAME LOOSE FROM THE ADHESIVE AND CONSEQUENTLY PULLED THE CATHETER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409904 ↗MalfunctionMay 29, 2024Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow
IT WAS REPORTED PURPLE LUMEN ON POWER PICC SOLO PLUGGED. PICC WOULD NOT FLUSH ONCE IN PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19419758 ↗MalfunctionApr 2, 2024Material Frayed; Material Frayed
IT WAS REPORTED, "A 5 FR PICC CATHETER WAS INSERTED, BUT WHEN THE GUIDEWIRE WAS INSERTED, IT DIDN'T PROGRESS. WHEN I TRIED TO REMOVE IT TO START THE PROCEDURE AGAIN, IT GOT TANGLED UP "INSIDE THE PATIENT'S ARM". IN AN ATTEMPT NOT TO FORCE THE MATERIAL, I USED THE TECHNIQUE OF PULLING THE GUIDEWIRE SLIGHTLY, TURNING IT FROM SIDE TO SIDE. AFTER A FEW MINUTES, WITH SOME DIFFICULTY, I MANAGED TO PULL IT OUT, BUT ONLY PART OF IT CAME OUT, BROKEN AND "FRAYED", THE TIP OF THE WIRE REMAINED INSERTED IN THE PATIENT, BUT IT WAS POSSIBLE TO REMOVE IT BY GENTLY PULLING THE EXPOSED PART. IT WAS NOT POSSIBLE TO SEPARATE THE GUIDE WIRE BECAUSE IT CONTAINED BIOLOGICAL MATERIAL. THERE WAS NO DAMAGE, EXCEPT THAT THE PATIENT REMAINED WITHOUT THE CATHETER. THE CATHETER WASN'T EVEN INSERTED." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19024025 ↗InjuryJun 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PICC LEAKED, AS IT HAD A HOLE IN THE INVERTED CONE REGION. IT WAS NECESSARY TO REMOVE THE CATHETER FROM THE PATIENT AND PERFORM ANOTHER INSERTION PROCEDURE. 06/21/2023: ADD INFO RECEIVED. ON THE NIGHT SHIFT ON (B)(6) 2023 AT SIX O'CLOCK IN THE MORNING AT THE SHIFT CHANGEOVER, THE NURSE OBSERVED THE PATIENT VERY AGITATED DESPITE RECEIVING SEDATION IN CONTINUOUS INFUSION PUMP. WHEN THE NURSE WAS ON DUTY AND WENT TO ASSESS THE PATIENT, SHE OBSERVED THE WET SHEETS, AND THE PATIENT WAS VERY AGITATED. WHEN PERFORMING THE SAS (AGITATION AND SEDATION SCALE), SHE OBSERVED MEDICATION LEAKAGE WETTING THE SHEET. THE FRACTURE WAS EXTERNAL IN THE MIDDLE OF THE DORMONID AND FENTANYL AND THE NORADRENALINE WAS IMMEDIATELY TURNED OFF. PATIENT EXPERIENCED PSYCHOMOTOR AGITATION BECAUSE HE WAS UNDER OROTRACHEAL INTUBATION AND SEDATED. TREATMENT WAS PERFORMED IMMEDIATELY DUE TO THE RISK OF DRUG EXTRAVASATION AND THE LACK OF DELIVERY OF THE DRUG THERAPY OFFERED, WE DECIDED TO REMOVE THE CATHETER AND PERFORM A NEW PASSAGE. REPLACEMENT PROCEDURE WAS PERFORMED AT THE BEDSIDE BY THE INFUSION THERAPY TEAM NURSE. TEGADERM CHG 3M WAS USED TO SECURE THE DEVICE. THE PATIENT HAS AN ULNAR FRACTU
Patient problems: Confusion/ Disorientation; Increased Level of Consciousness
MAUDE report 17217879 ↗InjuryJan 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT IN A DOUBLE LUMEN PICC SOLO 5FR CATHETER, WHEN HANDLING MEDICATION FROM THE OTHER ACCESS, THE ACCESS WITH CONTINUOUS NORADRENALINE UNDERGOES INTERACTION, INCREASING THE PATIENT'S BLOOD PRESSURE. IT WAS NOT POSSIBLE TO REMOVE THE CATHETER FOR ANALYSIS DUE TO ITS DEPENDENCE ON MEDICATION. THERE WAS A NEED TO CUT OUT A ROUTE AND PUNCTURE A PERIPHERAL VEIN TO CONTINUE WITH INTERMITTENT MEDICATION WHILE THE PICC WAS EXCLUSIVELY FOR NORADRENALINE. 12/26/2022 ADDITIONAL INFORMATION: PATIENT IMPACTED DUE TO INCREASED BLOOD PRESSURE; CUSTOMER MAINTAINING POWER PICC SOLO N. 5 FR- DOUBLE LUMEN IN LEFT UPPER LIMB, INFUSING NORADRENALINE AT 0.03 MCG/KG/MIN IN AN EXCLUSIVE ROUTE; WHEN USING THE OTHER ROUTE, WHICH WAS SALINIZED, DURING THE ADMINISTRATION OF BOLUS DIPYRONE ANALGESIA, THE CLIENT PRESENTED PRESSURE INSTABILITY, BECOMING HYPERTENSIVE AND BRADYCARDIC, WITH A PALE LIP. IT WAS NECESSARY TO PUNCTURE AVP (PERIPHERAL VENOUS ACCESS) IN RIGHT UPPER LIMB WITH CATHETER 20 FOR INTERMITTENT MEDICATIONS. AFTER THE INCIDENT, WE CONTACTED THE REPRESENTATIVE, AND SHE WITNESSED THE MOMENT OF SALINIZATION OF THE CATHETER (THE PATIENT AGAIN PRESENTED PRESSURE INSTAB
Patient problems: Arrhythmia; High Blood Pressure/ Hypertension
MAUDE report 16098660 ↗MalfunctionMay 13, 2022Backflow; Backflow
NURSE, FROM THE INPATIENT UNIT, REPORTED BLOOD RETURN IN THE 5FR DOUBLE LUMEN PICC SOLO CATHETER. THIS RETURN HAPPENED MORE THAN 01 TIME WITH THE SAME PATIENT. THE NURSE DID NOT REPORT THE PATIENT'S CLINICAL CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14399999 ↗MalfunctionApr 15, 2022Material Deformation; Material Deformation
IT WAS REPORTED A 5FR D/L POWERPICC WITH A KINKED TLS STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14117634 ↗MalfunctionMar 1, 2022Material Frayed; Material Frayed
IT WAS REPORTED ON FRIDAY, (B)(6) 2022, ABOUT 5PM, DURING THE INSERTION OF A PICC CATHETER, THERE WAS AN OCCURRENCE DURING ITS USE. PICC CATHETER WAS ATTEMPTED TO BE PLACED IN ADULT PATIENT (ABOVE 60 YEARS OLD), IMPATIENT IN THE FACILITY. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ADVANCE THE CATHETER UNTIL ITS MARK ZERO, THE CATHETER WAS REMOVED FROM THE VEIN TO RESTART THE PROCEDURE FROM THE BEGINNING, AND THEN IT WAS NOTICED THAT ITS DISTAL END (THE LAST 5-7 CM) WAS WITH MEMORY (AN "ADDICTED" POSITION). SO, THE HYDROPHILIC STYLET WAS REMOVED AS WELL UNTIL ITS END SO IT COULD BE EVALUATED, AND IT WAS PRESENTING A FRACTURE IN ITS DISTAL END. INITIALLY, THE CATHETER WAS CUT IN 43CM. HOWEVER, IN THE FIRSTS INSERTION ATTEMPTS IT WAS NOT ADVANCING TILL ITS END, AND THERE WAS ALWAYS 11CM REMAINING OUTSIDE. DUE TO THE ADVANCING FAILURES, THE ENTIRE CATHETER WAS REMOVED AND EVALUATED THROUGHOUT ITS LENGTH, AND AT THIS MOMENT IT WAS IDENTIFIED THE MEMORY, AT THE SAME MOMENT THE STYLET WAS REMOVED TO BE EVALUATED. THE SECOND CUT OF THE CATHETER (MORE 11CM WERE CUT AWAY), WAS PERFORMED AFTER THE REMOVAL OF THE STYLET. IT WAS EVALUATED MORE CLOSELY AND IT WAS CONFIRMED THE FRACTURE OF THE HYDROP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13639205 ↗MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
SUPERVISOR NURSE OF THE INPATIENT UNIT, REPORTS THAT WHEN FLUSHING THE CATHETER, IT WAS LEAKING THROUGH THE INSERTION. AS THE PATIENT'S TREATMENT HAD ALREADY ENDED, THEY REMOVED THE PICC CATHETER AND FOUND CRACKS IN THE BODY OF THE CATHETER. ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROVIDER? (DETAIL) NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, ADMINISTRATION OF MEDICATIONS, ETC)? (DETAIL) NO. WAS THERE ANY EXPOSURE TO BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) THERE WAS NO EXPOSURE TO BLOOD/CHEMOTHERAPEUTICS, BUT SALINE SOLUTION AT THE TIME THE SATURATED DRESSING WAS OBSERVED. I WAS CALLED BY MY COLLABORATOR AND WHEN DOING A TEST WITH SALINE, I OBSERVED A RETURN OF SF0.9%, RETURNING BY INSERTION. I COMMUNICATED TO THE DOCTOR RESPONSIBLE FOR THE PATIENT AND, ACCORDING TO HIS INSTRUCTIONS, I REMOVED THE CATHETER, AS THE PATIENT'S ANTIBIOTIC THERAPY WOULD HAVE ENDED AND SHE WOULD BE DISCHARGED 1 DAY AFTER THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12210559 ↗MalfunctionJul 16, 2021Material Deformation; Material Deformation
IT WAS REPORTED THE MICRO-INTRODUCERS ARE NOT AS EASY TO INSERT. IT WAS FURTHER REPORTED THAT IF THE STAFF HAS DIFFICULTY ADVANCING IT INTO THE SKIN, THEY MAY HAVE TO TRY AGAIN WITH A DIFFERENT ONE FROM A SEPARATE KIT. THE MICROEZ MICROINTRODUCER 5.0 F WITH VESSEL DILATOR WERE IN THE POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET INSERTION PACKAGE. 06/24/2021: THE RETURNED MICROINTRODUCER WAS FOUND TO BE BUCKLED AND FOLDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12184340 ↗MalfunctionMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED "PICC INSERTED FOR AN ICU PATIENT ON ECMO, INSERTED USING ECG TECHNOLOGY AND CONFIRMED PLACEMENT AT CAJ. X-RAY TAKEN FOR REASONS OTHER THEN TIP CONFIRMATION, HOWEVER THE PICC TIP APPEARED TO BE MUCH DEEPER THEN CONFIRMED ON PLACEMENT. THE PICC WAS PULLED BACK FOR THIS REASON BUT A HOLE WAS NOTED IN THE POLYURETHANE WHEN PULLED BACK SO THE PICC WAS REMOVED. CUSTOMER DOES NOT HAVE A CAUSE OTHER THEN THE POSSIBILITY OF KINK FROM A POORLY PLACED DRESSING AND THE FACT THE PATIENT IS ON ECMO. THEY ARE CONCERNED THE POLYURETHANE OF THE PICC HAD BEEN STRETCHED DUE TO THE PATIENT RECEIVING ECMO. THE PICC ON INSERTION WAS IN THE CORRECT POSITION AND DESPITE NO CHANGE IN EXTERNAL MEASUREMENT APPEARED TO BE CLOSE TO THE TRICUSPID VALVE. UNFORTUNATELY THE PICC WAS NOT SAVED OR MEASURED POST REMOVAL." WAS THERE ANY PATIENT HARM REPORTED? NO. THIS REPORT ADDRESSES THE MALPOSITION OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886690 ↗MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "PICC INSERTED FOR AN ICU PATIENT ON ECMO, INSERTED USING ECG TECHNOLOGY AND CONFIRMED PLACEMENT AT CAJ. X-RAY TAKEN FOR REASONS OTHER THEN TIP CONFIRMATION, HOWEVER THE PICC TIP APPEARED TO BE MUCH DEEPER THEN CONFIRMED ON PLACEMENT. THE PICC WAS PULLED BACK FOR THIS REASON BUT A HOLE WAS NOTED IN THE POLYURETHANE WHEN PULLED BACK SO THE PICC WAS REMOVED. CUSTOMER DOES NOT HAVE A CAUSE OTHER THEN THE POSSIBILITY OF KINK FROM A POORLY PLACED DRESSING AND THE FACT THE PATIENT IS ON ECMO. THEY ARE CONCERNED THE POLYURETHANE OF THE PICC HAD BEEN STRETCHED DUE TO THE PATIENT RECEIVING ECMO. THE PICC ON INSERTION WAS IN THE CORRECT POSITION AND DESPITE NO CHANGE IN EXTERNAL MEASUREMENT APPEARED TO BE CLOSE TO THE TRICUSPID VALVE. UNFORTUNATELY THE PICC WAS NOT SAVED OR MEASURED POST REMOVAL." WAS THERE ANY PATIENT HARM REPORTED? NO. THIS REPORT ADDRESSES THE HOLE IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886237 ↗MalfunctionApr 2, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT POWERPICC SOLO CATHETER DEVELOPED MECHANICAL OCCLUSIONS(KINKING) IN-SITU AFTER INSERTION. THE INSERTION WAS UNREMARKABLE WITH NO DIFFICULTIES, FLUSHED AND ASPIRATED WITHOUT RESISTANCE ON INSERTION BUT PATIENT DEVELOPED OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11607451 ↗MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AFTER THE PICC WAS INSERTED AND GOT FLUSHED, THE FLUSH CAME OUT OF THE HOLE THAT WAS JUST BELOW THE HUB WHERE THE VALVE SITS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10050007 ↗MalfunctionFeb 24, 2018Device Dislodged or Dislocated
IT WAS REPORTED THAT PICC WAS INSERTED AT FACILITY USING 3CG TECHNOLOGY SUCCESSFULLY. SHERLOCK WAS USED TO TRACK THE PICC IN A DOWNWARDS DIRECTION; MAX P WAVE WAS ACHIEVED FOR CONFIRMATION OF PICC TIP. CHEST X-RAY PERFORMED POST PROCEDURE SHOWED THAT THE PICC TERMINATED IN THE AZYGOS VEIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7294460 ↗InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD PICC PLACED ON (B)(6) 2017, AND REMOVED ON (B)(6) 2017, DUE TO CLOT AND BREAK DOWN OF THE SKIN. THE PICC WAS REMOVED AND THE PATIENT HAD IT REPLACED WITH A POWERGLIDE. IT WAS STATED THE PATIENT MAY BE REACTING TO THE MATERIAL IN THE LINE.
Patient problems: Skin Erosion; Thrombus
MAUDE report 7260472 ↗MalfunctionJan 11, 2018Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT ON (B)(6) 2017 A PICC LINE SITED IN THE PATIENTS RIGHT BRACHIAL VEIN, WAS NOTED TO BE LEAKING FROM THE RED LUMEN WHEN BEING FLUSHED WITH STERILE SALINE PRE-TREATMENT. THE SKIN UNDER THE DRESSING WAS INTACT AND NO PHLEBITIS WAS PRESENT. A TEAR WAS VISIBLE IN THE LINE, ON INSPECTION. A REPLACEMENT PICC INSERTION WAS ARRANGED BEFORE FURTHER TREATMENT COULD BE ADMINISTERED. THE FAULTY LINE WAS INSERTED ON (B)(6) 2017, ONLY A FEW DAYS PRIOR TO THE FRACTURE APPEARING (MARK AT SKIN 17CM, DISTANCE TO HUB 27CM). A REPLACEMENT LINE WAS PLACED USING OVER THE WIRE TECHNIQUE (B)(6) 2017. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7184133 ↗MalfunctionSep 28, 2017Malposition of Device
IT WAS REPORTED THAT ON (B)(6) 2017, THE PICC WAS INSERTED ON (B)(6) 2017, USING SHERLOCK TCS. THE TIP POSITION WAS CONFIRMED USING THE SHERLOCK DEVICE WITH A SMALL P WAVE ELEVATION ONLY AND NO XRAY WAS REQUIRED. ON (B)(6) 2017, AN XRAY WAS ORDERED FOR A POSSIBLE NON-RELATED ISSUE AND THE TIP OF THE PICC WAS FOUND TO BE IN THE IVC. THE HEALTHCARE PROFESSIONAL ORDERED TO PULL BACK THE PICC BY 8CM.
Patient problems: No Information
MAUDE report 6900846 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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