BioFlo 02-804Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI H965103028040), received between Jun 24, 2016 and Jan 13, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIOFLO DURAMAX 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. DURING A DIALYSIS TREATMENT, AN AIR LEAK (MICROBUBBLES) CAUSED THE ALARM TO GO OFF. THE CATHETER WAS TESTED BY CLAMPING THE CATHETER AND AIR WAS ABLE TO BE ASPIRATED IN THE ARTERIAL LIMB. DUE TO THIS, THE DIALYSIS TREATMENT WAS STOPPED. THE CATHETER WAS SURGICALLY REPLACED TWO DAYS LATER UNDER LOCAL ANESTHESIA, AND REGULAR DIALYSIS WAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058338 ↗
• MalfunctionJan 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A CATHETER FROM A BIOFLO DURAMAX 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. THE CUSTOMER REPORTS THE DURAMAX CATHETER WAS IMPLANTED (B)(6) 2024. FOR THREE MONTHS AFTER INSERTION, THE SUTURE WING WAS SUTURED TO THE PATIENT. HOEVER, AST THE TIME OF THE EVENT IT WAS NOT. ON (B)(6) 2024 WHILE ONGOING HEMODIALYSIS THE PATIENT ACCIDENTALLY PULLED OUT HIS CATHETER WITHOUT MUCH STRENGTH. FORTUNATELY THE DIALYSIS MACHINE STOPPED IMMEDIATELY. THE LINE WAS NOT REPLACED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079925 ↗
• MalfunctionNov 8, 2023Fracture; Fracture

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO DURAMAX 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. 6 MONTHS POST PROCEDURE, THE CATHETER WAS FOUND TO BE CUT/FRACTURED NEAR THE CUFF. THE CATHETER DID NOT FUNCTION AS WELL AS IT SHOULD HAVE DURING A DIALYSIS PROCEDURE THAT USES HIGH PRESSURE. AS THE PHYSICIAN STARTED TO REMOVE THE CATHETER FROM THE PATIENT, THE CATHETER CUT/FRACTURED PROXIMAL TO THE CUFF, INSIDE OF THE PATIENT. THE DOCTOR WAS ABLE TO REMOVE THE RETAINED TUBING WITH A CLAMP. THE CATHETER WAS REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT WAS REPORTED AS STABLE DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092400 ↗
• MalfunctionSep 18, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE NATIONAL COMPETENT AUTHORITY FOR MEDICAL DEVICE PROBLEMS, BASG, OF AUSTRIA NOTIFIED ANGIODYNAMICS OF AN EVENT THAT OCCURRED WITH A BIOFLO DURAMAX DIALYSIS CATHETER. THE END USER REPORTED THERE WAS A SPONTANEOUS LEAK BETWEEN THE ADAPTER AND THE TUBING. A NUMBER OF CASES HAVE ALREADY OCCURRED IN VIENNA. IT IS REASONABLE TO CONCLUDE THE CATHETER WAS REMOVED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765989 ↗
• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN (B)(6) HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646043 ↗
• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN VIENNA AUSTRIA HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645942 ↗
• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN VIENNA AUSTRIA HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645935 ↗
• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN VIENNA AUSTRIA HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645934 ↗
• MalfunctionFeb 22, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ISSUE WITH THEIR DURAMAX BIOFLO DIALYSIS CATHETER. IT WAS RECENTLY NOTICED THAT THE PATIENT HAD "COATINGS" OF THE CATHETER MATERIAL ON THE THIGH FROM THE CATHETER. THE MATERIAL HAS NOT RUBBED OFF ON THE PATIENT MORE THAN ONCE. THE PATIENT WAS DIALYSING WITH FRAGMIN 7500 E/HD, AND THE LEGS OF THE CATHETER WERE PLUGGED WITH DURA LOCK. THE CATHETER WAS LOCKED AT 30% CITRATE. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DURAMAX. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418021 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED THERE WAS A LEAK IN THE EXTENSION OF THE DURAMAX BIOFLO CATHETER IN THE EXTENSION OF THE CATHETER BRANCH, AT THE JUNCTION POINT OF THE TRANSPARENT EXTENSION WITH THE LUER. THE CATHETER WAS REMOVED AND WILL BE 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 15496132 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED THERE WAS A LEAK IN THE EXTENSION OF THE DURAMAX BIOFLO CATHETER IN THE VENOUS BRANCH, AT THE JUNCTION POINT OF THE TRANSPARENT EXTENSION WITH THE LUER. THE CATHETER WAS REMOVED AND WILL BE 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 15496123 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED THERE WAS A LEAK IN THE EXTENSION OF THE DURAMAX BIOFLO CATHETER IN THE EXTENSION OF THE CATHETER BRANCH, AT THE JUNCTION POINT OF THE TRANSPARENT EXTENSION WITH THE LUER. THE CATHETER WAS REMOVED AND WILL BE 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 15496066 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED THERE WAS A LEAK IN THE EXTENSION OF THE DURAMAX BIOFLO CATHETER IN THE VENOUS BRANCH, AT THE JUNCTION POINT OF THE TRANSPARENT EXTENSION WITH THE LUER. THE CATHETER WAS REMOVED AND WILL BE 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 15496014 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED THERE WAS A LEAK IN THE EXTENSION OF THE DURAMAX BIOFLO CATHETER IN THE EXTENSION OF THE CATHETER BRANCH, AT THE JUNCTION POINT OF THE TRANSPARENT EXTENSION WITH THE LUER. THE CATHETER WAS REMOVED AND WILL BE 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 15496013 ↗
• MalfunctionSep 13, 2022Material Puncture/Hole; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN ISSUE WITH A DIALYSIS WITH BIOFLO CHRONIC DIALYSIS CATHETER. IT WAS REPORTED AIR WAS ENTERED INTO THE BLOOD SYSTEM THROUGH A HOLE IN THE PLASTIC TRANSPARENT ARTERY TUBE UNDER THE CLAMP. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412073 ↗
• MalfunctionMay 20, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  DURING A DIALYSIS TREATMENT, BLOOD WAS NOTED TO BE LEAKING FROM THE ATERIAL LUMEN OF THE BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM. INITIALLY, THIS WAS REPORTED AS A SMALL BLOOD LEAK; HOWEVER, IT LATER BECAME HEAVY AND PREVENTED THE PATIENT'S DIALYSIS TREATMENT FROM BEING COMPLETED. PATCHES WERE USED TO COMPRESS AND MINIMIZE THE BLOOD LOSS UNTIL CATHETER WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453278 ↗
• MalfunctionMay 19, 2022Leak/Splash; Leak/Splash

  DURING A DIALYSIS TREATMENT, THE PATIENT'S BIOFLO CHRONIC DIALYSIS CATHETER, BEGAN TO LEAK UNDER THE RED LUER NECK. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS AND AIR ASPIRATION; HOWEVER, FOLLOW UP DETERMINED THAT THERE WAS ACTUALLY NO BLOOD LOSS. THE TREATMENT WAS ABORTED DUE TO THIS ISSUE. IT WAS REPORTED THE CATHETER HAD BEEN PLACED APPROXIMATELY A YEAR PRIOR TO THIS EVENT. CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433809 ↗
• MalfunctionJan 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE 1 OF 4: AN END USER REPORTED AN ISSUE WITH 4 BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KITS. IT WAS REPORTED THAT DURING 4 SEPARATE OCCURRENCES WITH THE SAME PATIENT, IMPLANTED CATHETERS HAVE DEVELOPED A KINK, IN THE PATIENT'S NECK. DURING THIS OCCURRENCE, THE DEVICE WAS PLACED ON (B)(6) 2021, RE-POSITIONED ON (B)(6) 2021, AND ULTIMATELY NEEDED TO BE REMOVED ON (B)(6) 2021, DUE TO THE KINK. THE KINK WAS NOTED VIA IMAGING. IT WAS REPORTED THAT NO TREATMENTS OR ACCESS WAS MADE TO THE CATHETER PRIOR TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266604 ↗
• MalfunctionJan 17, 2022Material Twisted/Bent; Material Twisted/Bent

  AN END USER REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KITS. DURING THIS OCCURRENCE FOR PATIENT B, THE CATHETER PLACED ON (B)(6) 2021 BUT WAS BROUGHT BACK IN ON (B)(6) 2021 DUE TO A KINK IN THE DEVICE. THE CATHETER WAS REMOVED AND REPLACED. IT WAS REPORTED THE CATHETER HAD NOT BEEN ACCESSED PRIOR TO THIS ISSUE. 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 13266603 ↗
• MalfunctionJan 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE 2 OF 4: AN END USER REPORTED AN ISSUE WITH 4 BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KITS. IT WAS REPORTED THAT DURING 4 SEPARATE OCCURRENCES WITH THE SAME PATIENT, IMPLANTED CATHETERS HAVE DEVELOPED A KINK, IN THE PATIENT'S NECK. DURING THIS OCCURRENCE, THE DEVICE WAS PLACED ON (B)(6) 2021, AFTER REMOVAL OF THE FIRST CATHETER. INFUSION WAS UNABLE TO BE PERFORMED, THEREFORE IMAGING WAS PERFORMED WHICH SHOWED THE CATHETER HAD KINKED. THE CATHETER WAS REMOVED AND REPLACED WITH A TEMPORARY CATHETER ON (B)(6) 2021 WHICH REMAINED INDWELLING UNTIL (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266601 ↗
• MalfunctionJan 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE 3 OF 4: AN END USER REPORTED AN ISSUE WITH 4 BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KITS. IT WAS REPORTED THAT DURING 4 SEPARATE OCCURRENCES WITH THE SAME PATIENT, IMPLANTED CATHETERS HAVE DEVELOPED A KINK, IN THE PATIENT'S NECK. DURING THIS OCCURRENCE, THE TEMPORARY CATHETER THAT WAS PLACED ON (B)(6) 2021, WAS REMOVED AND REPLACED ON (B)(6) 2021 WITH A PERMANENT CATHETER. THAT SAME DAY, THERE WAS A NOTED KINK WITH THE THIRD CATHETER, THEREFORE IT WAS REMOVED AND REPLACED WITH A NEW ONE THAT SAME DAY. THE CATHETER HAD BEEN INDWELLING FOR A SHORT PERIOD OF TIME BEFORE THE ISSUE WAS NOTED VIA IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266599 ↗
• MalfunctionJan 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE 4 OF 4: AN END USER REPORTED AN ISSUE WITH 4 BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KITS. IT WAS REPORTED THAT DURING 4 SEPARATE OCCURRENCES WITH THE SAME PATIENT, IMPLANTED CATHETERS HAVE DEVELOPED A KINK, IN THE PATIENT'S NECK. DURING THIS OCCURRENCE, THE CATHETER PLACED ON (B)(6) 2021 WAS REMOVED DUE TO DIFFICULTY ENCOUNTERED WHEN INFUSING. IT WAS REPLACED WITH A DIFFERENT DEVICE, IN THE PATIENT'S GROIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266598 ↗
• MalfunctionJul 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AN END USER REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. A FEW DAYS AFTER THE INITIAL PLACEMENT OF THE DEVICE, THE CUFF WAS VISIBLE OUTSIDE OF THE PATIENT'S BODY AND IT WAS REPORTED THAT THE CATHETER DID NOT FUNCTION CORRECTLY. THE CATHETER HAD PARTIALLY SLID OUT OF THE PATIENT WHEN USED ON THE DIALYSIS MACHINE. SINCE IT WAS STILL FUNCTIONAL, IT WAS DETERMINED TO CONTINUE USING IT. IT WAS STATED THAT THE "ARTERIAL POLE WAS NOT RETRACTABLE; HOWEVER, THE VENOUS SIDE WORKED." IN MID- MAY, THE VENOUS POLE BECAME LESS EFFECTIVE AND HIGH RECIRCULATION WAS NOTED DURING DIALYSIS TREATMENT. THERE WAS ALSO BLOOD LEAKAGE NOTED FROM THE INSERTION SITE, MONTHS LATER, ON (B)(6) 2021. ULTIMATELY, THE CATHETER WAS REMOVED FROM THE PATIENT ON 06/26/2021, AFTER THE LAST USE ON (B)(6) 2021. THE LOCATION OF THE CATHETER TIP PLACEMENT OR EXACT LOCATION OF THE DEVICE IN THE PATIENT IS UNKNOWN AND IT IS UNKNOWN WHY THE CATHETER MOVED. DUE TO THE PATIENT HAVING A MASSIVE THROMBI, A NEW PICC COULD NOT BE PLACED IN THE UPPER BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210053 ↗
• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A VASCULAR SURGEON REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. THE PATIENT HAD A NEW TUNNELED CATHETER PLACED ON (B)(6) 2020. AT THE START OF THE FIRST DIALYSIS TREATMENT ON (B)(6) 2021, A HEMATOMA OCCURRED NEAR THE CATHETER AND THE PATIENT EXPERIENCED A LOT OF PAIN. ON (B)(6) 2020 A FLEBOGRAM WAS MADE AND, WITH INSERTION OF CONTRAST, EXTRAVASCULAR FLUID WAS IDENTIFIED IN THE TUNNELED TRAJECTORY. THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2021. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hematoma

  MAUDE report 11798005 ↗
• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A VASCULAR SURGEON REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM DUAL VALVE SHEATH BASIC KIT. THE CATHETER WAS PLACED ON (B)(6) 2018; HOWEVER, ON 12/21/2020, CRACKS WERE NOTED ON THE WHITE PART OF THE ARTERIAL POOL. ON (B)(6) 2020, THE CATHETER WAS REMOVED DUE TO A LEAK AND A NEW DEVICE WAS PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798002 ↗