MAUDE Adverse Event Report: C. R. BARD / BARD ACCESS SYSTEMS, INC. PINPOINT GEL CAP; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Item 9a10000 - no guide gel caps have been discovered with contamination.This is the 3rd event since (b)(6) 2021, all events have been reported to (b)(6) without resolution.The issue has been identified in 3 different lots.Fda safety report id # (b)(4).

• Brand Name: PINPOINT GEL CAP
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): C. R. BARD / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 12835698
• MDR Text Key: 281074308
• Report Number: MW5105443
• Device Sequence Number: 2
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/16/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1