MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 6-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8726
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The single complaint was reported with multiple events.There are no additional details regarding additional patient events.Attempts were made to obtain the following information.If further details are received at a later date a supplemental medwatch will be sent.Specific number of procedure involved.For each procedure please provide following separately-: event date.Quantity involved.When did each involved device had the needle pulled off? lot involved.The following information was obtained: i was unable to get specific data on cases and dates as this happened over a several week period.Cases were cv and vascular.I was told that the needles were falling off right from the start or very early in the case.Note: events have been reported via mw 2210968-2019-82830, 2210968-2019-82831, 2210968-2019-82832, 2210968-2019-82834, 2210968-2019-82835.
Event or Problem Description
It was reported that the patient underwent a vascular or heart procedure on unknown date and suture was used.During the procedure, the needle is popping off very fast.The procedure was completed with another device of the same product code and different lots.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: twenty-two representative samples of product code m8726, lot # mhp815 were returned for evaluation.The complaint sample was not received.The product code is multistrand count and each packet contains four strands double armed.During the visual inspection of thirteen 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 strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.Per the conditions of the samples received, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number mph815, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: PRLNE BLU 4X24IN 6-0 D/A C-1
• 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: 8705864
• Report Number: 2210968-2019-82837
• Device Sequence Number: 11359385
• Product Code: GAW
• UDI-Device Identifier: 10705031045927
• UDI-Public: 10705031045927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 12/31/2023
• Device Catalogue Number: M8726
• Device Lot Number: PAH747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 06/25/2019
• Patient Sequence Number: 1