MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 9-0 S/A BV100-4; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2829G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that the distributor facility received suture.They noted a strand of hair inside the packaging.The device was not used on a patient.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: investigation summary: it was reported that the device had foreign matter issues.There was no sample received for analysis.Only a picture of the sample was received for analysis.During the visual inspection of the picture, a sample of product code 2829 could be observed and no foreign matter were noted.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.

• Brand Name: ETHLN BLK 5IN 9-0 S/A BV100-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8524901
• Report Number: 2210968-2019-80477
• Device Sequence Number: 19429124
• Product Code: GAR
• UDI-Device Identifier: 10705031004108
• UDI-Public: 10705031004108
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 2829G
• Device Lot Number: MBK198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1