MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 11-0 S/A BV50-3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2881G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Investigation summary: it was reported packaging foreign matter non-biological / unknown.According to the information received, it was received for analysis an unopened sample of product code 2881, lot pd6708.During the visual inspection of an unopened sample, a detached needle was observed placed in the seal area but not compromising the sterile barrel, since the needle no trough totally the seal area of the overwrap.The manufacturing records were reviewed, and the manufacturing / packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of packaging foreign matter non-biological was a needle, suture and/or tab in the seal.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, it was found that there had been a foreign substance in the package before use.The product was not used for the patient.There were no adverse patient consequences.Upon evaluation of a returned device, the needle was in the seal of the packaging.

• Brand Name: ETHLN BLK 5IN 11-0 S/A BV50-3
• 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: 9139271
• Report Number: 2210968-2019-88256
• Device Sequence Number: 2607246
• Product Code: GAR
• UDI-Device Identifier: 10705031004191
• UDI-Public: 10705031004191
• 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): 09/05/2019

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: 03/31/2024
• Device Catalogue Number: 2881G
• Device Lot Number: PD6708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1