BioFlo 75014Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H965750140), received between Jun 21, 2016 and Nov 8, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (NON-VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. IT WAS REPORTED THE HUB WAS FOUND TO BE CRACKED AT THE CLOSURE OF THE TPN INFUSION PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094824 ↗
• MalfunctionJul 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PICC PLACED IN THE ICU. AS SOON AS THE NURSE LEFT THE ICU ONE OF THE HUBS FELL OFF THE DUAL LUMEN PICC. THE PICC NURSE DID AN OVER-THE-WIRE EXCHANGE WITH A NEW PICC. SHE CHECKED THE HUBS ON THE 2ND PICC AND THEY WERE SECURE. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6744558 ↗
• MalfunctionFeb 22, 2017Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED BY NURSE PRO PLUS, AN IV SERVICES COMPANY, PICC PLACED AT (B)(6) MEDICAL CENTER DEVELOPED A "PIN HOLE IN THE EXTENSION (TUBING) CAUSING LEAKAGE." THE LINE WAS REMOVED AND REPLACED. THE PATIENT CONDITION WAS REPORTED AS "UNAFFECTED" AND THE DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349707 ↗
• MalfunctionFeb 22, 2017Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED BY NURSE PRO PLUS, AN IV SERVICES COMPANY, PICC PLACED AT ROANE MEDICAL CENTER DEVELOPED A "PIN HOLE IN THE EXTENSION (TUBING) CAUSING LEAKAGE." THE LINE WAS REMOVED AND REPLACED. THE PATIENT CONDITION WAS REPORTED AS "UNAFFECTED" AND THE DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349680 ↗
• InjuryFeb 22, 2017Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED BY NURSE PRO PLUS, AN IV SERVICES COMPANY, PICC PLACED AT THE (B)(6) MEDICAL CENTER DEVELOPED A "PIN HOLE IN THE EXTENSION (TUBING) CAUSING LEAKAGE." THE LINE WAS REMOVED AND ANOTHER PICC WAS PLACED THE DAY AFTER. THE PATIENT HAD AN INFECTION WHICH WAS SUSPECTED TO BE THE RESULT OF THE HOLE IN THE EXTENSION TUBING. THE PATIENT HAD THE PICC LINE IN PLACE FOR MORE THAN TWO MONTHS PRIOR TO THE HOLE BEING DISCOVERED IN THE LINE. THE PATIENT WAS DISCHARGED AND RE-ADMITTED TWICE PRIOR TO THE HOLE IN THE LINE BEING NOTICED. THE PATIENT HAD ORIGINALLY BEEN ADMITTED FOR A GUNSHOT WOUND AND RECEIVED NUMEROUS MEDICATIONS THROUGH THE PICC LINE BOTH AS AN INPATIENT AND AS AN OUTPATIENT. THE USED PICC WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 6349664 ↗
• MalfunctionSep 21, 2016Material Rupture; Material Rupture

  AS REPORTED, DURING POWER INJECTION OF 5ML/SEC., THE PICC CATHETER TUBING BURST AT APPROXIMATELY THE 0CM MARK. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5966419 ↗
• MalfunctionSep 21, 2016Material Rupture; Material Rupture

  AS REPORTED, DURING POWER INJECTION OF 5ML/SEC., THE PICC CATHETER TUBING BURST AT APPROXIMATELY THE 0CM MARK. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5966405 ↗
• MalfunctionSep 21, 2016Material Rupture; Material Rupture

  AS REPORTED, DURING POWER INJECTION OF 5ML/SEC., THE PICC CATHETER TUBING BURST AT APPROXIMATELY THE 0CM MARK. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5966384 ↗
• MalfunctionAug 24, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  PICC PLACED INTO A PATIENT PRIOR TO THE PATIENT GOING TO A CAT SCAN. WHILE GETTING CONTRAST INFUSED, THE PICC STARTED TO LEAK BETWEEN THE "0" MARK ON THE CATHETER AND THE WHITE SUTURE WING, RESULTING IN THE CATHETER BEING REMOVED. IT HAD ONLY BEEN IN PLACE FOR A FEW HOURS. THE PATIENT CONDITION WAS REPORTED AS "STABLE." THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5900558 ↗
• MalfunctionAug 24, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  PICC PLACED INTO AN ICU PATIENT WITH SEVERAL DRIPS INFUSING. WITHIN A FEW HOURS THE PICC STARTED LEAKING ("PIN HOLE" LEAKAGE) BETWEEN THE "0" MARK ON THE CATHETER AND THE WHITE SUTURE WING, RESULTING IN THE CATHETER BEING REMOVED. THE PATIENT CONDITION WAS REPORTED AS "STABLE." THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5900551 ↗
• MalfunctionJun 21, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE PATIENT EXPERIENCED LEAKING AT THE PICC INSERTION SITE, RESULTING IN THE PICC BEING REMOVED. THE USED DEVICE WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5739720 ↗