MAUDE Adverse Event Report: ETHICON INC. SURGICAL GUT SUTURE - CHROMIC; SUTURE, ABSORBABLE, NATURAL

Catalog Number NW4246

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The actual sample was returned for analysis.The needle was found to be bent.No further investigation can be performed on the actual sample as the sample was contaminated with the blood and in open condition.Retain samples were reviewed and all the needle testing values were found to be above requirements.

Event Description

It was reported that a patient underwent an episiotomy repair procedure on (b)(6) 2016 and suture was used.While closing the superficial layer the needle got disfigured.There was no adverse consequence to the patient.

• Brand Name: SURGICAL GUT SUTURE - CHROMIC
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BADDI; plot no- 58-b, epip phas 1 jha; rmajri; baddi 17320 5; IN 173205
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5910286
• MDR Text Key: 53343504
• Report Number: 2210968-2016-11639
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NW4246
• Device Lot Number: B5021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1