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Peripheral Catheter Insertion Kit F320088TRecalls & reported problems

Bard Access Systems, Inc. · PowerGlide 20Ga, 8cm · Class 2

All models of Peripheral Catheter Insertion Kit (54)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741140723), received between Apr 27, 2018 and Jun 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4
  • Failure to Advance1
  • Retraction Problem1
  • Sticking1

Patient problems

  • Foreign Body In Patient3
  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 13, 2025Break; Break

    IT WAS REPORTED VIA MEDWATCH, A RIGHT 20G 8CM POWERGLIDE PRO MIDLINE WAS PLACED IN THE RIGHT CEPHALIC VESSEL. HAD GOOD BLOOD RETURN (LAB WORK RETRIEVED), BUT RESISTANCE WAS MET WITH FLUSH X2 ATTEMPTS. THE CATHETER WAS REMOVED, BUT THE PLASTIC TIP WAS NOT INTACT (1CM), WIRE NOTED TO BE INTACT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 22206832 ↗
  • InjuryMay 23, 2025Break; Break

    IT WAS REPORTED BY CUSTOMER THAT THE POWERGLIDE CATHETER SHEER. ADDITIONAL INFORMATION RECEIVED ON 5/6/2025: ARM XRAY, CHEST XRAY, AND TTE COMPLETED WITHOUT INCIDENT. NO CHANGES TO PATIENTS'. ASSESSMENT. DISCHARGED ON ANTICOAGULANTS (ALREADY REQUIRED FOR OTHER HEALTH DIAGNOSIS).

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

    MAUDE report 22079298 ↗
  • InjuryMay 21, 2025Break; Break

    IT WAS REPORTED, RIGHT POWERGLIDE PRO 8CM 20G PLACED IN THE RIGHT CEPHALIC VESSEL. POWERGLIDE WOULD NOT FLUSH. UPON REMOVAL, THE CATHETER'S FULL LENGTH WAS NOT NOTED. PINK HUB CATHETER WAS PLACED NEXT TO ANOTHER CATHETER OF SAME LENGTH FOR COMPARISON. APPEARS TO BE SHEARED WITH 1-2CMS OF CATHETER TIP MISSING. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 22066152 ↗
  • InjuryMay 21, 2021Break; Break

    IT WAS REPORTED "POWERGLIDE PRO CATHETER BROKE IN PATIENT BODY. DR HAD TO SURGICALLY REMOVE REMAINING CATHETER." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/11/2021: IT WAS REPORTED BY HEALTH PROFESSIONAL "I FILLED OUT A MIDAS WITH THE EVENT. THE PATIENT IS STILL IN THE UNIT IF ADDITIONAL INFORMATION IS NEEDED FOR PT NAME, ETC. THE LINE WAS BEING INSERTED AND WHILE ADVANCING THE CATHETER RESISTANCE WAS MET SO WHEN THE WIRE WAS PULLED BACK THERE WAS MORE RESISTANCE SO WHEN I REMOVED THE DEVICE I NOTED THAT THERE WAS PARTIAL CATHETER INTACT. I PALPATED AND FELT WHAT WAS SUSPECTED TO BE THE RETAINED CATHETER IN THE SKIN. A TOURNIQUET WAS PLACED LIGHTLY IN THE AXILLA REGION AND THE DR WAS PAGED IMMEDIATELY. CATHETER WAS REMOVED AT BEDSIDE WITH MINIMAL HARM BUT COULD HAVE POTENTIALLY BEEN HARMFUL. THE CATHETER WAS IN THE PATIENTS SUBCUTANEOUS AREA RATHER THAN ALL THE WAY IN THE VEIN. THE PATIENT WAS BEING TREATED ORIGINALLY FOR CANCER AND HAS SINCE HAD MORE GO ON. THE PATIENT HAD DIFFICULT VASCULATURE WHICH IS WHY A POWERGLIDE WAS CHOSEN. NO INFECTIOUS DISEASES NOTED FOR PATIENT. ALL OF THE MISSING CATHETER WAS ALSO RETRIEVED WE USED A MEASURING TAPE TO BE POSI

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11866444 ↗
  • MalfunctionApr 27, 2018Retraction Problem; Sticking; Failure to Advance

    IT WAS REPORTED POWERGLIDE PRO 8 CM 20 GAUGE CATHETER INSERTED INTO A PATIENT. AFTER VEIN ACCESSED, THE GUIDEWIRE ADVANCED WITH NO PROBLEM, WHEN THE CATHETER ADVANCED IT ONLY ADVANCED HALFWAY. RETRACTED THE CATHETER AND ATTEMPTED TO RETRACT THE GUIDEWIRE BUT IT WAS STUCK IN THE ADVANCED POSITION. THE ENTIRE MIDLINE PULLED OUT OF THE PATIENTS SKIN AND THE GUIDEWIRE HAD SHEARED, UNCOILED, AND THE UNCOILED PORTION WAS STICKING OUT OF THE PATIENT¿S SKIN. SHEARED PORTION OF THE GUIDEWIRE WAS THEN COMPLETELY REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7469913 ↗

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Sources and updates

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