MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8434H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information: the actual device batch number associated with this event is not known.The following are reported possible batch numbers: batch kke654 mfg date: 9/1/2016, exp date: 8/31/2021.Batch kea866 mfg date: 5/30/2016, exp date: 4/30/2021.Batch mkh785 mfg date: 9/14/2018, exp date: 8/31/2023.In addition, a review of the batch manufacturing records for the possible batch numbers kke654, kea866, mkh785 was conducted and the batches met all finished goods release criteria.Investigation summary: an unopened sample of product code 8434, lot # kke654 was returned for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, or damaged 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 conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.Unopened samples of product code 8434, lot # kea866 were returned for analysis.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged 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 received, no performance pull off - suture needle was found, and the tested samples met the finished goods requirements.Unopened samples of product code 8434, lot # mkh785 were returned for analysis.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged 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 received, no performance pull off - suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used for wound closure.During the procedure, the doctor was using suture to close an abdominal incision and the needle came off of the suture, prematurely.The doctor used another suture to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PROLENE SUT 30IN(75CM) 0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9732100
• Report Number: 2210968-2020-01314
• Device Sequence Number: 19609934
• Product Code: GAW
• UDI-Device Identifier: 10705031015593
• UDI-Public: 10705031015593
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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 Model Number: 8434H
• Device Catalogue Number: 8434H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1