MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A PSL; SUTURE, NONABSORBABLE, SILK

Model Number	590H
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Attempts have been made to retrieve the device.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 during an inspection, a foreign matter was noticed in the suture package, which appeared to be hair.No patient involvement reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 11/16/2020 h3 evaluation: a picture was received for evaluation.Upon to visual inspection of picture a sealed packet of product with a foreign matter (hair) into the overwrap packet could be observed.Also, a sealed packet of product was received for evaluation.During the visual inspection of the sealed sample, a foreign matter (hair) into the overwrap packet could be observed.The foreign matter defect has been correlated to the manufacturing process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SILK BLK 30IN 0 S/A PSL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10708138
• Report Number: 2210968-2020-08161
• Device Sequence Number: 11490343
• Product Code: GAP
• UDI-Device Identifier: 10705031006478
• UDI-Public: 10705031006478
• Combination Product (Y/N): N
• 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): 10/09/2020

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: 02/28/2025
• Device Model Number: 590H
• Device Catalogue Number: 590H
• Device Lot Number: QCBHPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1