MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 36IN 0 S/A CT; SUTURE, ABSORBABLE, NATURAL

Catalog Number	914H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mlu013 batch number, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a c-section surgery on (b)(6) 2019 and suture was used.The needle popped off of the suture at the swage.Changed to another device to complete the surgery.There were no adverse consequences to the patient.

• Brand Name: GUT CHR UD 36IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9193424
• Report Number: 2210968-2019-88448
• Device Sequence Number: 2486530
• Product Code: GAL
• UDI-Device Identifier: 10705031022683
• UDI-Public: 10705031022683
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 914H
• Device Lot Number: MLU013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1