MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number A897516

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Event Description

Upon opening a foley catheter kit, it was noted that the 10 ml prefilled sterile water syringe for inflating the bulb was missing.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 8424076
• MDR Text Key: 138899293
• Report Number: 8424076
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A897516
• Device Catalogue Number: A897516
• Device Lot Number: NGCT2752
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Weight: 59