MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 30IN 5-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH7477H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number mlj740-eph7477, and no non-conformances were identified.Investigation summary: it was received for analysis one unopened sample of product code eph7477, lot mlj740.During the visual inspection of the representative sample, no defects were found on the package.The sample was opened and contain a strand per packet.The suture was dispensed without problem and examined along of the strand and no defects, damaged or fraying suture was observed.A tactile test was performed to strand and no unraveling or fraying could be detected.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection of the sample received, no fraying suture were observed.
Event or Problem Description
It was reported that the patient underwent carotid artery repair on an unknown date and suture was used.The suture frayed when passing through the vascular prosthesis.The suture was changed to successfully complete the procedure.There were no adverse patient consequences reported.

• Brand Name: PRLNE HS BLU 30IN 5-0 D/A C-1 EP
• 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: 8923680
• Report Number: 2210968-2019-86027
• Device Sequence Number: 16743364
• Product Code: GAW
• UDI-Device Identifier: 10705031233454
• UDI-Public: 10705031233454
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/29/2019

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: 09/30/2023
• Device Catalogue Number: EPH7477H
• Device Lot Number: MLJ740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1