MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8710
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: an opened sample of product was returned for evaluation.During the visual inspection of the sample, a foreign matter, hair, under foam park into the straight pack folder could be observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition the assignable cause of the foreign matter is a hair.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and the suture was used.It was reported that during surgery, when opening the package, it was found that there had been a foreign substance like a hair on the needle park foam.There were no adverse patient consequences reported.

• Brand Name: PROLENE SUTURE 30"(75CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9681957
• Report Number: 2210968-2020-01012
• Device Sequence Number: 2756805
• Product Code: GAW
• UDI-Device Identifier: 10705031045842
• UDI-Public: 10705031045842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 04/30/2024
• Device Model Number: M8710
• Device Catalogue Number: M8710
• Device Lot Number: PEB834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/07/2020
• Patient Sequence Number: 1