MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NEEDLE COUNTER; NEEDLE, SUTURING, DISPOSABLE

Catalog Number SNE73SPVLI

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Needle counter magnet peeling away from plastic case.Discovered prior to the procedure and a new one obtained.The procedure proceeded without complications.Fda safety report id# (b)(4).

• Brand Name: NEEDLE COUNTER
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; waukegan IL 60085
• MDR Report Key: 8678928
• MDR Text Key: 147450374
• Report Number: MW5087181
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: SNE73SPVLI
• Device Lot Number: 219889
• Was Device Available for Evaluation?: Yes
• 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 Age: 43 YR
• Patient Weight: 71