MAUDE Adverse Event Report: ETHICON, INC ETHICON PSD VIOLET MONOFILAMENT SUTURE; SUTURE, SURGICAL, ABSORABLE

Lot Number MA6600

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

Scrub tech was removing suture from internal packaging when the needle broke.

• Brand Name: ETHICON PSD VIOLET MONOFILAMENT SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORABLE
• Manufacturer (Section D): ETHICON, INC; somerville NJ 08876
• MDR Report Key: 8401416
• MDR Text Key: 138237942
• Report Number: MW5084710
• Device Sequence Number: 1
• Product Code: NEW
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Lot Number: MA6600
• 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