MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 5-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8725
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.No specific information regarding quantity of devices has been provided.The following information was requested, but unavailable: please provide specific number of devices which failed in this procedure.=>no further information is available.Of the devices which failed in this procedure- how many sutures broke? no further information is available.How many needles pulled off? no further information is available.Did all the devices fail during actual use on patient? if no, please explain when did each device failed; in the package/ during dispensing (before use on patient) or during suturing (actual use on patient).No further information is available.
Event or Problem Description
It was reported by the sales rep that during a cardiovascular procedure some sutures were not swaged firmly, causing sutures to come off the needles.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/03/2020.Additional h3 device evaluation summary: one hundred seventy-eight samples of product code m8725, lot # pej602 were returned for analysis.A functional test was performed to thirty-two samples 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.According to results of the functional test, no performance pull off - suture needle was found, and the tested samples met the finished goods requirements.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/17/2020.A manufacturing record evaluation was performed for the finished device batch pej602, m872519 and no non-conformances were identified.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.

• Brand Name: PRLNE BLU 4X24IN 5-0 D/A C-1
• 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: 9459452
• Report Number: 2210968-2019-90814
• Device Sequence Number: 3091411
• Product Code: GAW
• UDI-Device Identifier: 10705031045910
• UDI-Public: 10705031045910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 04/30/2024
• Device Model Number: M8725
• Device Catalogue Number: M8725
• Device Lot Number: PEJ602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 01/17/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/17/2020; 02/03/2020
• Patient Sequence Number: 1