MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 4-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3557H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular surgery on (b)(6) 2019 and suture was used.The suture was broken other than knot during use.It was commented that the suture did not come in contact with sharp thing.Another lot product was used with no problem.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/19/2019.Investigation summary: two opened boxes of unopened samples of product code 3557h, lot # mkq514 were returned for evaluation.The complaint sample was not received for analysis.During the visual inspection of 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 noted.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 breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: PRNVA BLU 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8858109
• Report Number: 2210968-2019-85097
• Device Sequence Number: 11336585
• Product Code: GAW
• UDI-Device Identifier: 10705031004504
• UDI-Public: 10705031004504
• Combination Product (Y/N): N
• PMA/510(K) Number: K001625
• 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): 07/08/2019

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: 08/31/2023
• Device Catalogue Number: 3557H
• Device Lot Number: MKQ514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/19/2019
• Patient Sequence Number: 1