MAUDE Adverse Event Report: C. R. BARD, INC. BARD 16X18 BIOPSY NEEDLE

Lot Number REDP0085

Device Problems Misfire (2532); Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Pt for a liver biopsy; during the procedure the 16x18 bard device did not properly fire.Lot # redp0085.Fda safety report id # (b)(4).

• Brand Name: BARD 16X18 BIOPSY NEEDLE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 8560572
• MDR Text Key: 143550385
• Report Number: MW5086236
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REDP0085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 84