MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	A182H
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot kbk414, and no non-conformances were identified.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 a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, when opening the package, it was found that a white suture had been tied with a black suture on the left and right.Another package was used.There were no adverse consequences to the patient.No additional information was available.

• Brand Name: SILK SUTURE 18"(45CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9981634
• Report Number: 2210968-2020-03284
• Device Sequence Number: 17292608
• Product Code: GAP
• UDI-Device Identifier: 10705031022966
• UDI-Public: 10705031022966
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 03/26/2020

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: 01/31/2021
• Device Model Number: A182H
• Device Catalogue Number: A182H
• Device Lot Number: KBK414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1