Catheter And Tube, Suprapubic
Gastroenterology, Urology · 21 CFR 876.5090
Recent MDR events
17 adverse event reports on file
- RAY BONANNO CATHETER S/SUOct 16, 2023InjuryBecton Dickinson2618282-2023-00084
- RAY BONANNO CATHETER S/SUOct 16, 2023InjuryBecton Dickinson2618282-2023-00083
- RAY BONANNO CATHETER S/SUOct 16, 2023InjuryBecton Dickinson2618282-2023-00085
- BD BONNANO¿ CATHETER TRAYJul 22, 2022MalfunctionBd Caribe Ltd.2618282-2022-00036
- BD BONNANO¿ CATHETER TRAYJun 27, 2022MalfunctionBd Caribe Ltd.2618282-2022-00030
- BD BONNANO¿ CATHETERNov 19, 2021MalfunctionBd Caribe Ltd.2618282-2021-00068
- TRAY BONANNO CATHETER S/SUSep 9, 2021MalfunctionBd Caribe Ltd.2618282-2021-00053
- TRAY BONANNO CATHETER S/SUFeb 26, 2021MalfunctionBd Caribe Ltd.2618282-2021-00015
- BD TRAY BONANNO CATHETER S/SUFeb 4, 2020InjuryBd Caribe Ltd.2618282-2020-00003
- TRAY BONANNO CATHETER S/SUAug 1, 2019MalfunctionBd Caribe Ltd.2618282-2019-00232
Event type breakdown
Recalls
2 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1610-2022 · View FDA record ↗ - LABORIE MEDICAL TECHNOLOGIES, CANADA ULCTerminatedUnknown
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladde
This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets.
Z-2535-2020 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code