MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1916G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional evaluation summary: an empty opened box, an empty opened overwrap packet and a labeled winding former with a needle-suture combination inside an opened foil were returned for analysis.During visual inspection of the opened sample, and seal area in the overwrap was noted to be as expected.The opened foil was examined and no wrinkles, defects or damaged were noted on the seal area.Due to condition of the opened sample, the assignable cause of packaging integrity cannot be determined since no defects were observed on the packet.Representative samples were returned for evaluation.During visual inspection of the overwrap packets, no defects or damaged were found.The samples were opened and the foils were examined for visual defects (appearance, color packages , wrinkles in the seal area, continuous seals, seal margins, over-sealing , damage (torn, punctured).No defects or damaged were observed on the samples.According to the samples condition the assignable cause cannot be determined since no defects were observed on the packets.
Event or Problem Description
It was reported during an unknown procedure the customer noticed the suture packet was unsealed, affecting the sterility of the packet.An additional packet was used to complete the procedure.There were no patient consequences reported.

• Brand Name: GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP
• 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: 8529163
• Report Number: 2210968-2019-80504
• Device Sequence Number: 2515997
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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: No Information
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1916G
• Device Lot Number: LB6637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1