BioFlo 60M701102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H96560M7011020), received between Oct 24, 2020 and Aug 29, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2023Fracture; Difficult to Remove; Stretched; Fracture; Difficult to Remove; Stretched

  AN END USER REPORTED AN ISSUE WITH A CAN 5F DL BIOFLO PASV NURSING TRAY ((B)(6) HOSPITAL (STP) KIT. THE PICC PLACEMENT PROCEDURE WAS STARTED. THE PATIENT'S RIGHT BASILIC VEIN WAS ACCESSED APPROXIMATELY 8-10CM ABOVE THE AC WITHOUT DIFFICULTY. NO CHALLENGES WITH VASCULAR ANATOMY WERE NOTED ON ASSESSMENT. NO VISIBLE DAMAGE TO THE GUIDEWIRE WAS NOTED PRIOR TO INSERTION. ULTRASOUND WAS USED TO ASSIST WITH PICC INSERTION. THE GUIDEWIRE THREADED THROUGH NEEDLE WITHOUT DIFFICULTY. ONCE RESISTANCE WAS FELT, ADVANCEMENT OF THE WIRE WAS HALTED, AND REMOVAL OF THE GUIDEWIRE WAS ATTEMPTED. THE ACCESS NEEDLE WAS REMOVED WITH NO ISSUES. THE GUIDEWIRE WAS EMOVED UNTIL APPROXIMATELY THE LAST 2/3CM. AN ULTRASOUND OF ARM WAS PERFORMED, VERIFYING THAT THE WIRE WAS NOT IN THE VEIN. A LARGER DERMATOTOMY WAS MADE WITH A SCALPEL TO ASSIST WITH REMOVING THE WIRE. THE WIRE STARTED TO STRETCH, WITH THE POTENTIAL TO SHEER AT THAT POINT, SO FURTHER REMOVAL ATTEMPTS WERE HALTED AND REFERRAL TO IR WAS MADE. THE SITE WAS COVERED WITH A LARGE TRANSPARENT OCCLUSIVE DRESSING TO SECURE EVERYTHING IN PLACE. IMPACT OF INCIDENT: THE WIRE COULD NOT BE REMOVED, AND THEREFORE THE PATIENT REQUIRED INTERVENTIONAL RADIOLOGY F

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17644365 ↗
• MalfunctionApr 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD FOUR EPISODES OF BLOOD BACKING UP INTO BOTH LUMENS OF THEIR 5F DL BIOFLO PICC WITH PASV . THESE EPISODES OCCURRED NOT IN RELATION TO HYDRATION INFUSION, BUT WERE NOTED WHEN PATIENT LIFTED THEIR ARMS TO CHANGE CLOTHING. THERE WAS NO DAMAGED NOTED TO THE PICC, THE NEEDLESS CONNECTOR WAS TIGHT AND THE PATIENT AVOIDED BOTTOMING OUT NS FLUSH SYRINGES WHEN FLUSHING THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE PATIENT HAD DECLINED REMOVAL AND REPLACEMENT OF THE CATHETER DUE TO POOR VENOUS ACCESS. THE FREQUENCY OF USE WAS 4 DAYS WEEKLY AT THE PATIENT'S HOME AND IN THE HOSPITAL. THE CATHETER WAS FLUSHED AFTER USE WITH SALINE AND WAS BEING USED FOR IV HYDRATION. IT WAS LATER REPORTED THAT ON (B)(6) 2023, DUE TO WITHDRAWAL OCCLUSION BOTH LUMENS (CATHFLO INSTILLATION INEFFECTIVE), THE PICC WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715867 ↗
• MalfunctionMar 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  A SENIOR CLINICAL RISK ADVISOR REPORTED AN ISSUE WITH A BIOFLO PICC W/PASV. ONE DAY AFTER DEVICE PLACEMENT, BLOOD WAS DRAWN FROM THE DEVICE AND RESULTS OF THE BLOOD CHEMISTRIES WERE REPORTED AS HEMOLYZED. BLOOD WORK WAS REPEATED UPON ADMISSION, AS MORE BLOOD WORK ORDERS WERE RECEIVED FROM INPATIENT PHYSICIANS; THEREFORE, BLOOD WORK WAS DRAWN FROM THE BIOFLO PICC AND BOTH LUMENS FLUSHED WELL AND HAD BLOOD RETURN. IT WAS NOTED; HOWEVER, THAT BLOOD RETURN WAS SOMEWHAT SLOWER TO DRAW. THE RESULTS OF THIS SECOND DRAW WERE RETURNED AND CHEMISTRIES WERE HEMOLYZED AGAIN. THE DOCTOR AND RESEARCH NURSE WERE NOTIFIED AND BLOOD WORK WAS REORDERED FOR PERIPHERAL LEVELS. IF PERIPHERAL BLOOD WORK YIELDS NON-HEMOLYZED RESULTS, WILL HAVE TO CHANGE ALL BLOOD WORK TO PERIPHERAL COLLECTION WHICH IS EVERY 6 HOURS AT MINIMUM AS PATIENT IS ON TUMOR LYSIS (TLS) MONITORING. THIS PICC WAS INSERTED FOR CYTOKINE RELEASE SYNDROME POTENTIAL AND TLS BLOOD WORK COLLECTION AND IT IS NOT USEFUL. THERE WAS NO REPORTED HARM OR ADVERSE EVENT EXPERIENCED BY THE PATIENT. IT WAS INDICATED THAT THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528407 ↗
• MalfunctionOct 24, 2020Fracture; Fracture

  A SENIOR CLINICAL RISK ADVISOR REPORTED AN ISSUE WITH A 5F BIOSTABLE PICC W/PASV. DURING THE PATIENT'S FOLLOW UP APPOINTMENT, THE PICC WAS NOTED TO BE FRACTURED. THE FRACTURE WAS LOCATED AT THE 6CM EXTERNAL MARK. THE PICC WAS REMOVED AND THE PATIENT'S DOCTOR WAS NOTIFIED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. 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 10731887 ↗