MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A CC-1 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8721H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the needle pulled off from suture.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/14/2020.Additional information: d10, h6 additional information: d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch pgj494, expiration date: 05/31/2024.Date of mfg.: 06/20/2019.Batch paj227, expiration date: 12/31/2023.Date of mfg.: 01/24/2019 batch phr809, expiration date: 06/30/2024.Date of mfg.: 07/17/2019 in addition, a review of the manufacturing record evaluations for the possible batch numbers pgj494, paj227, phr809 were performed for the finished device lot, and no non-conformances were identified.Additional h3 investigation summary: it was reported that the device had performance pull off - suture needle.It was received for analysis unopened samples of product code 8721h, lot phr809.The complaint sample was not returned for analysis.During the visual inspection of the 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 conditions of the sample received, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.It was received for analysis unopened samples of product code 8721h, lot pgj494.The complaint sample was not 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 conditions of the sample received, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.It was received for analysis an unopened sample of product code 8721h, lot paj227.The complaint sample was not returned for analysis.During the visual inspection of the sample, no defects were found on the packet.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.

• Brand Name: PRLNE BLU 36IN 5-0 D/A CC-1 MP
• 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: 9375405
• Report Number: 2210968-2019-90310
• Device Sequence Number: 13968251
• Product Code: GAW
• UDI-Device Identifier: 10705031019737
• UDI-Public: 10705031019737
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/08/2019

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 Catalogue Number: 8721H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1