MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 8-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8754H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/30/2019
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.Additional information was requested and the following was obtained: how was case completed? no further information is available.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain: no further information is available.Device return status/ follow up: when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2019 and suture was used.During interrupted suturing to the coronary anastomosis the suture was broken.The operation time was extended 30 minutes.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/01/2019.A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.H3 device evaluation summary: five unopened samples of product code ep8754, lot jlj816 were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of five 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, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: PRLNE BLU 30IN 8-0 D/A BV175-8 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: 8928268
• Report Number: 2210968-2019-86099
• Device Sequence Number: 11269843
• Product Code: GAW
• UDI-Device Identifier: 10705031207462
• UDI-Public: 10705031207462
• Combination Product (Y/N): N
• 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): 07/30/2019

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: 09/30/2020
• Device Catalogue Number: EP8754H
• Device Lot Number: JLJ816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1