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Groshong 7712800Recalls & reported problems

Bard Access Systems, Inc. · Groshong Replacement Connector for Groshong 8F Single Lumen CV Catheter · Class 2

All models of Groshong (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741087028), received between Apr 10, 2018 and Nov 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Reports received per month

Nov 2023: 1 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: 0 reportsJun 2025: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Fluid/Blood Leak1
  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT ONE YEAR, ELEVEN MONTHS, AND TWENTY-SEVEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE FLUID ALLEGEDLY LEAKED IN THE CONNECTOR. REPORTEDLY, THE LEAK SEEMED TO BE CAME FROM THE CONNECTOR BECAUSE AFTER CHANGING IT, THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18110539 ↗
  • MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7712800 PORT AND CATHETER ACCESSORIES ALLEGEDLY EXPERIENCED A DETACHMENT OF DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) MALE PATIENT WAS (B)(6).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8822596 ↗
  • MalfunctionApr 10, 2018Break; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE PHYSICIAN IS HAVING REPEATED BREAKS IN THE EXTERNAL HUB OF THE GROSHONG, THIS IS ALLEGEDLY HAPPENING AT LEAST ONCE A MONTH. THE PHYSICIAN STATES THAT IT IS HAPPENING WITH THE INITIAL DEVICE AND THE REPAIR KIT. HE STATED THAT IT HAS BEEN HAPPENING FOR YEARS AND HE THINKS IT IS A DESIGN FLAW. HE REPORTED THAT IT BREAKS A THE END EVERY TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7419465 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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