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

Catalog Number 724G

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Representative samples were returned for evaluation.Visual and functional inspections for ductility were performed and the samples met the requirements.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported by a veterinarian that an animal underwent an unknown procedure on (b)(6) 2015 and suture was used.During the procedure, the needle bent after a few passes.

• 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.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5311786
• MDR Text Key: 33907836
• Report Number: 2210968-2015-20873
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 724G
• Device Lot Number: JDM739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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