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	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2019 and suture was used.During the procedure, the needle popped off the suture while suturing at the sewage.Case completed with another device of the same product code.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Additional: it was reported that the device had performance pull off - suture needle.It was received for analysis an opened foil with an empty folder, a detached needle and a suture of product code 914h.During the visual inspection of the needle, the swage and attachment area were noted to be as expected.Marks could be observed on the edge of the needle that appears to be by the use of a surgical instrument.Also, remnant of the suture was observed into the barrel hole.The end of the suture was noted cut appear to be by use of a surgical instrument.To avoid this kind of damage the packages insert (ifu) cautions: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the tip.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.A manufacturing record evaluation was performed for the finished device mpm877 batch number, and no non-conformances were identified.

• 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: 9213359
• Report Number: 2210968-2019-88867
• Device Sequence Number: 2244799
• 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,Followup
• Report Date (Section B): 09/24/2019

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: 11/30/2023
• Device Catalogue Number: 914H
• Device Lot Number: MPM877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1