MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8934H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the patient underwent an unknown cardiovascular procedure on (b)(6) 2019 and suture was used.The needle was detached from the suture during continuous suturing though no extra force was applied.It was not a control release needle.Further details are not available.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch maj580-8934h and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis two unopened samples of product code 8934, lot maj580.During the visual inspection of two samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PROLENE SUTURE 36"(90CM) 5-0 BLU
• 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: 8689891
• Report Number: 2210968-2019-82638
• Device Sequence Number: 16629562
• Product Code: GAW
• UDI-Device Identifier: 10705031022058
• UDI-Public: 10705031022058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/14/2019

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: 12/31/2022
• Device Catalogue Number: 8934H
• Device Lot Number: MAJ580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/21/2019
• Patient Sequence Number: 1