MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, NATURAL

Catalog Number	G123H
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional evaluation summary: there was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the pictures, an unopened sample with a foreign matter inside of the package could be observed.However, no conclusion could be reach as the sample was not returned for analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.
Event or Problem Description
It was reported what seems to be, a small bug was noticed in the outer sterile packaging.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 08/14/2019.Additional h-3 summary: one unopened overwrap packet of product code g123, lot mkk173 was returned for analysis.During the visual inspection, no defects were found on the overwrap package; however, dark spots were observed on the copolymer.In additon no bug was found.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According the sample conditions the assignable cause is foreign matter.Representative samples: twenty unopened overwrap pakets of product code g123, lot mkk173 were returned for analysis.During visual inspection of thirteen unopened samples, no foreign matter, bug or defects were observe on the packets.Per the condition of the sample received, no packaging foreign matter -biological was found.

• Brand Name: GUT CHR UD 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8620901
• Report Number: 2210968-2019-81487
• Device Sequence Number: 16206874
• Product Code: GAL
• UDI-Device Identifier: 10705031037458
• UDI-Public: 10705031037458
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 08/31/2023
• Device Catalogue Number: G123H
• Device Lot Number: MKK173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1