MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8737
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? no.Action taken when event occurred? suture replacement.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences.No.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Investigation summary: it was reported that the device had performance pull off.Suture needle.It was received for analysis an unopened sample of product code epm8737, lot mme293.During the visual inspection of the sample, the swage and attachment area were noted to be as expected, also, the tip and body of the needle was examined under magnification and no defects, damages or bending needle were found.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.
Event or Problem Description
It was reported that a patient underwent a cabg procedure in (b)(6) 2019 and suture was used.During the procedure, the needle detached from the suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 2X24IN 7-0 D/A BV175-6 EP
• 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: 8676367
• Report Number: 2210968-2019-82476
• Device Sequence Number: 14081001
• Product Code: GAW
• UDI-Device Identifier: 10705031207479
• UDI-Public: 10705031207479
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 05/09/2019

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: 10/31/2023
• Device Catalogue Number: EPM8737
• Device Lot Number: MME293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1