MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 30IN 6-0 D/A C-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	3706H
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
(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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2019 and suture was used.The suture deswaged on routine use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/24/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformities were identified.Additional information: d4, d10, h4.H3 evaluation: it was received for analysis an opened box with unopened samples of product.During the visual inspection of thirteen 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 the strands with no defects observed.A functional test was performed using 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 condition of the samples, no suture needle pull off was found, and the tested samples met the finished goods requirements.

• Brand Name: PRNVA BLU 30IN 6-0 D/A C-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9359221
• Report Number: 2210968-2019-90195
• Device Sequence Number: 13959616
• Product Code: GAW
• UDI-Device Identifier: 10705031004627
• UDI-Public: 10705031004627
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/05/2019

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: 12/31/2023
• Device Model Number: 3706H
• Device Catalogue Number: 3706H
• Device Lot Number: PAJ579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1