BioFlo 45812Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI H965458120), received between May 17, 2016 and May 19, 2026 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Device Dislodged or Dislocated

  A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED IN THE RIGHT INTERNAL JUGULAR VEIN. THE PATIENT HAD TO UNDERGO PERIPHERAL IV CANNULATION AND THEIR LAST IV TREATMENT WAS ADMINISTERED VIA A PERIPHERAL IV CANNULA INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216315 ↗
• MalfunctionMay 18, 2026Device Dislodged or Dislocated

  A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED IN THE RIGHT SUBCLAVIAN VEIN. THE PATIENT HAD TO HAVE NEW PICC INSERTED AND PREVIOUS PICC REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211762 ↗
• MalfunctionMay 18, 2026Device Dislodged or Dislocated

  A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED AND KINKED IN THE PATIENT'S ARM. THE PICC LINE HAD TO BE REMOVED AND A NEW PICC HAD TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211761 ↗
• MalfunctionJul 9, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED. THE PATENT WAS HAVING TREATMENT THROUGH THE PICC. DURING CHEMO INFUSION (AROUND AND HOUR THROUGH A 3 HOUR TAXOL), THE PATENT REPORTED THE SLEEVE OF CLOTHING FELT DAMP AND NOTED A WET PATCH JUST UNDERNEATH WHERE THE PICC LINE WAS. THE INFUSION WAS STOPPED AND PICC SITE CHECKED- ALL INTACT. THEY CHECKED THE GIVING SET AND ALL INTACT. THEY RAN A SALINE FLUSH AND NOTICED A VERY FINE CRACK ON THE HUB OF THE PICC (LIKELY FROM WHERE THE MICROCLAVE HAS BEEN SECURED TOO TIGHTLY) AND THIS IS WHERE THE INFUSION WAS LEAKING FROM. THEY ADVISED THE PATENT THAT UNFORTUNATELY THEY WILL NEED TO REMOVE THE PICC LINE AS IT IS NO LONGER USEABLE DUE TO DAMAGE. THE PICC WAS REMOVED BUT NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461848 ↗
• MalfunctionNov 13, 2023Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A PICC FROM BIO-STABLE 4F SL 55CM MST-70 KIT,VALVED.DURING ROUTINE FLUSHING OF THE PICC, IT WAS NOTED THAT IT WAS LEAKING FROM THE CONNECTION BELOW THE PURPLE HUB. THE TUBING WAS CRACKED. THE PICC WAS REMOVED THAT SAME DAY AND REPLACED TWO DAYS LATER. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120932 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT. APPROXIMATELY 39 DAYS POST PROCEDURE, THE PICC DRESSING WAS REMOVED, THE LINE WAS FLUSHED, AND SALINE SPURTED OUT AT AROUND THE 4CM LEVEL. SECURACATH WAS IN PLACE AS WELL WITH LINE AT 4CM EXTERNAL LENGTH. PER THE PATIENT, ON ONE OCCASION OF BLOOD SAMPLING, IT IS BELIEVED THAT THE NURSE MAY HAVE USED A NEEDLE NEXT TO THE PICC, PUNCTURING THE DEVICE. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407880 ↗
• MalfunctionMay 14, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A VASCULAR ACCESS NURSE PRACTITIONER REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 PICC. THE PICC LINE WAS PLACED WHILE THE PATIENT WAS ON THE ITU (INTENSIVE CARE UNIT) BY THE BEDSIDE. ON THE DAY OF THE INSERTION THE LINE WAS FLUSHED AND ASPIRATING WELL FOLLOWING TRUST GUIDELINES WITHOUT ANY ISSUES. THE FOLLOWING DAY, ON FOLLOWUP ASSESSMENT, IT WAS NOTED THERE WAS A LEAK FROM THE SIDE OF THE LINE. THE LINE WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW OF THE SAME LINE. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826007 ↗
• MalfunctionFeb 1, 2021Crack; Crack

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOSTABLE PICC. ON DAY 321 OF CHEMOTHERAPY TREATMENT, IT WAS NOTED, AFTER FLUSHING, THAT THE PICC WAS LEAKING FROM THE LUMEN, AROUND THE 4CM MARK ON THE SHAFT OF THE PICC , WHICH WAS JUST AT THE INSERTION SITE. A SMALL "PIN PRICK" LIKE HOLE WAS DISCOVERED ON THE DEVICE. THIS DEVICE WAS REPLACED WITH ANOTHER BIOSTABLE PICC SO THE PATIENT COULD CONTINUE CHEMO TREATMENT. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11261132 ↗
• MalfunctionJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR'S CUSTOMER: PICC LEAKED/DETACHED AT JUNCTION WITH EXTENSION TUBING AND SUTURE WING. PICC DETACHED AT WING - DETACHMENT OF CATHETER AT JUNCTION WITH PICC SUTURE WINGS/EXTENSION. PICC WAS SITED ON (B)(6) 2019, OUTPATIENT CHEMOTHERAPY (FEC) GIVEN (B)(6) 2019. PICC REDRESSED AND FLUSHED ON (B)(6) 2019, AND (B)(6) 2019, REPORTED BY PATIENT TO BE WORKING WELL ON ALL OCCASIONS. ADMITTED TO HOSPITAL AS EMERGENCY ON (B)(6) 2019. BLOOD CULTURE SAMPLES TAKEN PERIPHERALLY, BUT NOT FROM PICC. PATIENT REPORTED PICC LEAKING WHEN FLUSHED AND NOT USED AGAIN AS HAD CANNULA. PROBLEM REFERRED TO PICC TEAM TO REVIEW, AND ON (B)(6) 2019, FOUND TO BE FRACTURED. PICC WAS WELL SECURED AND SUPPORTED BY THE DRESSING. SECURA-CATH IN SITU TO RETAIN THE PICC IN PLACE. PICC WAS REMOVED BY PULLING AND COMPLETE. TIP SENT FOR CULTURE. EXIT SITE IN GOOD CONDITION. PATIENT WILL NEED TO HAVE PICC REPLACED FOR NEXT CYCLE OF CHEMOTHERAPY IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554780 ↗
• MalfunctionJul 10, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE UK, "ICC SITED IN LEFT BASILIC VEIN UNDER ULTRASOUND GUIDANCE ON (B)(6) 2019. PICC TIP LOCATED IN LOWER THIRD SVC. PATIENT RECEIVING CHEMOTHERAPHY AS AN OUTPATIENT. THE PICC LINE WAS BEING CARED FOR IN THE COMMUNITY AND VYGON BIOCONNECTOR USED TO COVER THE END OF THE PICC. CONTACTED ON MAY 14, 2019 BY DAY THERAPY AS LINE LEAKING WHEN FLUSHED. ON INSPECTION, HAIRLINE CRACK SEEN IN LUER CONNECTOR. THE CATHETER WAS REMOVED AND RETAINED." A NEW PICC HAS BEEN PLACED IN THE PATIENT FOR CONTINUATION OF CHEMO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775441 ↗
• MalfunctionApr 26, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), AN INDWELLING PICC HAS A FINE HAIRLINE CRACK AFFECTING THE LUER CONNECTOR CAUSING LEAKAGE WHEN FLUSHED. THE PICC WAS SITED IN THE RIGHT BASILIC VEIN UNDER ULTRASOUND GUIDANCE ON (B)(6) 2019 WITH THE PICC TIP LOCATED IN THE LOWER THIRD SVC. THE PATIENT WAS RECEIVING CHEMOTHERAPY AS AN OUTPATIENT. THE PICC LINE WAS BEING CARED FOR IN THE COMMUNITY AND A VYGON BIOCONNECTION WAS USED TO COVER THE END OF THE PICC. A BECTON-DICKINSON QSITE MAY ALSO HAVE BEEN USED. NO PATIENT COMPLICATIONS OR INJURY WAS INCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554715 ↗
• InjuryApr 4, 2019Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), WHILE PLACING A PICC: "ON CANNULATION, GUIDEWIRE NOT ADVANCING, THEN UNABLE TO WITHDRAW WIRE. MORE LOCAL ANAESTHETIC GIVEN AND FURTHER ATTEMPT MADE TO WITHDRAW WIRE UNSUCCESSFULLY. ADVICE SOUGHT FROM VASCULAR SURGEON WHO ADVISED THAT IT COULD BE WITHDRAWN USING MORE FORCE. WIRE FINALLY PULLED FREE BUT SOFT TIP UNRAVELLED. ON X-RAY EXAMINATION OF PATIENTS'S UPPER ARM, WIRE FRAGMENT SEEN TO BE RETAINED. PATIENT TRANSFERRED TO ANOTHER HOSPITAL, AND VASCULAR SURGEONS SURGICALLY REMOVED FRAGMENT UNDER GENERAL ANAESTHETIC. " THE GUIDEWIRE HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8482140 ↗
• MalfunctionMar 26, 2019Reflux within Device; Reflux within Device

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6): IMMEDIATELY AFTER PICC PLACEMENT, THE PATIENT WENT FOR CXR POST-INSERTION AS NORMAL. "CATHY THEN CHECKED THE PICC TO FIND BLOOD PUSHING BACK DOWN THE PICC AS IF THERE WAS NO VALVE ON THE END OF THE PICC. SHE HAD TO REMOVE THE PICC AND REPLACE WITH A NEW ONE". NO INJURY TO THE PATIENT WAS REPORTED. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8451147 ↗
• MalfunctionMar 5, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), AN INDWELLING PICC HAS A FINE HAIRLINE CRACK AFFECTING THE LUER CONNECTOR CAUSING LEAKAGE ON FLUSHING THE LINE WITH SALINE. THIS ISSUE WAS REPORTED ON (B)(6) 2019 BY THE COMMUNITY IV SERVICE DURING ROUTINE PICC CARE. THE PICC WAS PLACED ON (B)(6) 2018 FOR THE ADMINISTRATION OF CHEMOTHERAPY. PRIOR TO DISCOVERY OF THE LEAKING LUER CONNECTOR, THE PICC WAS LAST USED FOR TREATMENT ON (B)(6) 2019 WHEN IT WAS REPORTED THAT THERE WERE NO PROBLEMS AND THE LINE WAS FLUSHING WELL. THE NEEDLE FREE CONNECTOR COVERING THE CATHETER HUB WAS A SPIRIT MEDICAL SECURE CONNECT NEEDLE FREE CONNECTOR. ON (B)(6) 2019 A SECOND PROCEDURE TO REPLACE THE PICC BY EXCHANGE OF CATHETER OVER GUIDEWIRE WAS SUCCESSFUL. THE PATIENT EXPERIENCED SOME INCONVENIENCE AS AN EXTRA VISIT TO THE HOSPITAL WAS NECESSARY PROCEDURE BUT THEIR TREATMENT SCHEDULED WAS NOT INTERRUPTED THE REMOVED PICC WAS RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8390571 ↗
• MalfunctionMar 5, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), AN INDWELLING PICC HAS A FINE HAIRLINE CRACK AFFECTING THE LUER CONNECTOR CAUSING LEAKAGE ON FLUSHING THE LINE WITH SALINE. THE PICC WAS PLACED ON (B)(6) 2018 FOR THE ADMINISTRATION OF CHEMOTHERAPY. PRIOR TO DISCOVERY OF THE LEAKING LUER CONNECTOR, THE PICC WAS LAST USED FOR TREATMENT ON (B)(6) 2019 WHEN IT WAS REPORTED BY STAFF THAT THERE WERE NO PROBLEMS AND THE LINE WAS ASPIRATING AND FLUSHING EASILY. HOWEVER THE PATIENT HAS REPORTED TO US THAT THERE WAS SOME LEAKAGE WITH THE FINAL FLUSH. THE NEEDLE FREE CONNECTOR COVERING THE CATHETER HUB WAS A VYGON BIONECTOR. ON (B)(6) 2019 A SECOND PROCEDURE TO REPLACE THE PICC BY EXCHANGE OF CATHETER OVER GUIDEWIRE WAS SUCCESSFUL. THE PICC WAS REPLACED ON THE DAY OF THE NEXT TREATMENT CYCLE SO THIS WAS NOT INTERRUPTED. THE REMOVED PICC WAS RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8390569 ↗
• MalfunctionFeb 22, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), PICC PLACED ON (B)(6) 2018 WAS LOCATED IN THE LOWER THIRD SVC. THE PATIENT WAS RECEIVING CHEMOTHERAPY AS AN OUTPATIENT. THE PICC LINE WAS BEING CARED FOR "IN THE COMMUNITY" AND A VYGON BIO-CONNECTOR WAS USED TO COVER THE END OF THE PICC. ON (B)(6) 2019 THE IV TEAM REPORTED THE LINE AS LEAKING WHEN FLUSHED AND ON INSPECTION, A HAIRLINE CRACK WAS SEEN IN THE LUER CONNECTOR. THE PICC WAS REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361855 ↗
• MalfunctionJan 7, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), "FOLLOWING ROUTINE FLUSHING OF (THE PICC) IT WAS NOTICED THAT THE DEVICE WAS LEAKING FROM THE HUB WHICH HOUSES THE PASV (PRESSURE ACTIVATED SAFETY VALVE). A NEEDLE-FREE CONNECTOR WAS ATTACHED, AND THEN CHANGED, BUT A LEAK STILL PERSISTED. THE NEEDLE FREE CONNECTOR USED WAS A SPIRIT MEDICAL SECURE CONNECT NEEDLE FREE CONNECTOR (NFC) REF: (B)(4) LOT: E161237. IT IS UNCLEAR HOW LONG THE CONNECTOR WAS ON THE HUB. THE NFC ARE CHANGED WEEKLY DURING ROUTINE LINE CARE. THE TRUST IS CURRENTLY TRANSITIONING FROM USING VYGON BIONECTORS TO THE SECURE CONNECT NFC. THE MEMBER OF STAFF REMOVING THE SECURE CONNECT NFC STATED IT WAS DIFFICULT TO REMOVE. THE LINE WAS REMOVED FROM THE PATIENT AND BROUGHT OVER TO THE PICC TEAM, THE NFC WAS REMOVED BY ME AND THE LINE FLUSHED, THERE WAS LEAKAGE FROM THE SEAM ON THE PASV. THE PATIENT HAS THE LINE INSERTED ON (B)(6) 2018 FOR CHEMOTHERAPY. PRIOR TO DISCOVERY OF THE LEAKING CONNECTOR, THE PICC WAS LAST USED FOR TREATMENT ON (B)(6) 2018 WHERE IT IS REPORTED THAT THERE WERE NO PROBLEMS AND THE LINE WAS FLUSHING WELL. THE MEMBER OF STAFF IN THE COMMUNITY IV TEAM STATES THAT THE PREVIOUS WEEK (B)(6) 2018

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222108 ↗
• MalfunctionOct 31, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED REGARDING A HOSPITAL IN THE (B)(6): " THE PATIENT ARRIVED TO CLINIC WITH A PICC LINE. WHEN THE RESEARCH NURSE (RN) ATTEMPTED TO GET BLOODS FROM THE LINE, THE BOTTLES WEREN'T FILLING UP, SO THEY DECIDED TO FLUSH THE LINE. THE FLUSH SPILLED ALL AROUND THE LINE. THE RS REMOVED THE ADMINISTRATION SET (BLUE BUNG) TO REPLACE IT, AND THEN THEY REALISED THAT THE END OF THE LINE (PURPLE END OF THE LUMEN) WAS CRACKED, AND OPENED UP WHEN THEY TRIED TO ATTACH A NEW ADMINISTRATION SET." "4F SINGLE JUMEN PICC LINE BIOFLO LOT 5320266 WAS INSERTED TO RIGHT ARM, BRACHIAL VEIN UNDER ULTRA SOUND GUIDED. LINE CUT TO 42 CM AND AT 1 CM FROM EXIT. NO HARM TO PATIENT. INFORMED THE PATIENT THAT THE LINE WAS BROKEN, CALLED THE CVAD TEAM AND ASKED FOR ADVICE. THEY INFORMED US THAT THE LINE NEEDED TO COME OUT AS THE END CAN BE REPLACED ON ITS OWN. WE REMOVED THE LINE, GOT PERIPHERAL BLOODS WITH THE ASSISTANCE OF THE IV TEAM, AND BOOKED A NEW PICC LINE INSERTION FOR THE FOLLOWING DAY. THE TEAM CONTACTED THE CVAD TEAM FOR ADVICE, LINE WAS REMOVED, NEW PICC LINE INSERTION WAS BOOKED AND WAS DONE THE FOLLOWING DAY. BLOOD REQUIRED WAS TAKEN PERIPHERALLY. PATIENT WAS TREATED THE FOLLOWING DAY WHICH WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8024099 ↗
• MalfunctionSep 5, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A PICC WAS REMOVED AND REPLACED DUE TO A CRACK IN THE LUER LOCK. THIS WAS DISCOVERED BECAUSE OF LEAKAGE. NO PATIENT COMPLICATIONS WERE INCURRED. THE USED PICC HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847015 ↗
• InjuryJul 31, 2018Crack; Difficult to Remove; Crack; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), FOLLOWING COMPLETION OF CHEMO TREATMENT, REMOVAL OF PICC WAS ATTEMPTED IN THE OUTPATIENT DEPARTMENT OF (B)(6) HOSPITAL ON (B)(6) 2018. THE PICC "BECAME STUCK, THEN SNAPPED." THE PATIENT HAD HAD NO PRIOR PROBLEMS WITH THE PICC. THEY RETURNED TO THE HOSPITAL THE NEXT DAY AND HEAT, MASSAGE AND INSERTION OF A GUIDEWIRE WERE USED TO ATTEMPT REMOVAL. THIS WAS UNSUCCESSFUL, SO THE PATIENT WAS REFERRED TO THE VASCULAR SURGEONS AT (B)(6) HOSPITAL, WHERE THE PICC WAS SUCCESSFULLY REMOVED. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Discomfort

  MAUDE report 7736327 ↗
• MalfunctionDec 7, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), PATIENT HAD VALVED PICC PLACED ON (B)(6) 2017. FIRST CYCLE OF CHEMOTHERAPY GIVEN ON (B)(6) 2017. DURING "ROUTINE WEEKLY CATHETER MAINTENANCE FLUSHING WITH SALINE," THE PICC WAS NOTED TO BE LEAKING FROM THE EXTENSION TUBE. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7096101 ↗
• MalfunctionNov 14, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), THERE WAS A LONGITUDINAL FRACTURE OF A VALVED PICC DEVICE BEING USED FOR CHEMOTHERAPY. THE PICC HAD BEEN INSERTED ON (B)(6) 2017 AND WAS REMOVED ON (B)(6) 2017. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED CATHETER WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7027318 ↗
• InjuryJun 1, 2017Kinked; Difficult to Remove; Kinked; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6): "DURING A PICC PLACEMENT PROCEDURE A NEEDLE WAS PLACED IN THE RIGHT CEPHALIC VEIN UNDER ULTRASOUND GUIDANCE. GUIDEWIRE ADVANCED, THEN MET OBSTRUCTION. REMOVAL OF NEEDLE AND GUIDEWIRE ATTEMPTED. NEEDLE REMOVED, GUIDEWIRE REMAINED STUCK AND COULD NOT BE REMOVED BY PULLING. PATIENT REFERRED TO ANESTHETIC AND ON-CALL SURGICAL TEAMS WHO ATTEMPTED REMOVAL BY MANIPULATION. RADIOLOGICAL EXAMINATION SHOWED FLEXIBLE TIP OF GUIDEWIRE KINKED IN VEIN. GUIDEWIRE REMOVED UNDER LOCAL ANESTHETIC IN THEATRE BY CUT-DOWN INTO VEIN AND LIGATION." ALL USED DEVICES WERE DISCARDED AT THE HOSPITAL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6605873 ↗
• MalfunctionJan 4, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), "THE LUMEN OF A 4F BIOFLO PICC THROUGH WHICH CHEMOTHERAPY DRUGS WERE DELIVERED CRACKED ON DAY 33 OF USE." NO PATIENT COMPLICATIONS WERE REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6222771 ↗
• MalfunctionDec 12, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4): "PICC SITED IN RIGHT BASILIC VEIN UNDER ULTRASOUND GUIDANCE ON (B)(6) 2016. PICC TIP LOCATED IN LOWER THIRD SVC. PATIENT WEEKLY PACLITAXEL CHEMOTHERAPY AS AN OUTPATIENT . THE PICC LINE WAS BEING CARED FOR IN THE COMMUNITY AND VYGON BIONECTOR USED TO COVER THE END OF THE PICC.(MAY ALSON HAVE USED B.D Q-SITE). CONTACTED ON (B)(6) 2016 BY DAY THERAPY AS LINE LEAKING WHEN FLUSHED, ON INSPECTION HAIRLINE CRACK SEEN IN LEUR CONNECTOR. THE CATHETER WAS REMOVED AND RETAINED. PRODUCT CLEANED WITH (B)(4) CLEANING WIPES." THE USED CATHETER IS EXPECTED TO BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6165830 ↗