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
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a heart case on an unknown date and suture was used.It was reported that the suture needle unexpectedly popped off from the suture.The case was completed with another suture.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: it was received for analysis thirty-one unopened samples of product code m8726, lot mph780.During the visual inspection of thirteen samples, 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 sample met the finished goods requirements.It was received for analysis an empty overwrap, three empty folder and eight dispensed needle-sutures of product code m8726, lot mph780.During the visual inspection of the samples, the swage and attachment area were noted to be as expected.The sutures were 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 sample met the finished goods requirements.A manufacturing record evaluation was performed for the finished device batch mph780-m8726 and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Specific number of needles that pulled off the suture during this case? how many cases experienced needle pulling off suture?.

• 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: 8614324
• Report Number: 2210968-2019-81440
• Device Sequence Number: 3019938
• Product Code: GAW
• UDI-Device Identifier: 10705031045927
• UDI-Public: 10705031045927
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/23/2019

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: No Information
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: M8726
• Device Lot Number: MPH860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/12/2019
• Patient Sequence Number: 1