GP General Purpose Drainage Catheter GPL2-1230HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817640020066), received between May 15, 2025 and May 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Crack; Crack

  NARRATIVE FROM HEALTHCARE FACILITY: PATIENT PRESENTING WITH PERSISTENT RLQ PERIAPPENDICEAL ABSCESS, ASSOCIATED RECURRENT INFECTION, AND BROKEN/MALFUNCTIONING PERCUTANEOUS DRAIN. THE CURRENT MANAGEMENT FRAMEWORK IS TO HAVE THIS CAVITY FULLY DRAINED AND COLLAPSED AND THEN TO UNDERGO INTERVAL APPENDECTOMY. ON INITIAL ADMISSION EXAM, HR IN 120S, NO MEASURED FEVER IN ED, VERY TENDER IN RLQ. DRAIN NOT HOLDING SUCTION (LUER LOCK CRACKED). WBC 20. SEPSIS FLUIDS INITIATED. CT SCAN DEMONSTRATES PERSISTENT (BUT DECREASED) WALLED-OFF ABSCESS. PREVIOUS 8CM, NOW 5CM. THE HUB [LUER] OF THE DRAIN WAS FRACTURED. THEREFORE, THE JP [JACKSON-PRATT] BULB COULD NOT BE ATTACHED TO EFFECTIVELY DRAIN THE ABSCESS. THE DRAIN MALFUNCTION DIRECTLY LEAD TO ABSCESS PROGRESSION, ELEVATED WHITE BLOOD CELL COUNT AND FEVER. THE CLINICAL PICTURE WAS CONSISTENT WITH BACTEREMIA. THE PATIENT BECAME SO ILL, THAT SHE COULD NOT WAIT FOR OUTPATIENT TREATMENT. SHE CAME TO THE ER AND WAS DIRECTLY ADMITTED TO THE HOSPITAL. PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Bacteremia; High White Blood Cell Count

  MAUDE report 22030987 ↗