MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 36IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 on (b)(6) 2019 and suture was used.During the procedure, when passing the suture through the tissue, it ruptured.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > it was reported performance breakage suture.A paper lid and an empty winding former were returned for analysis.No suture or needle were returned for evaluation to determine the assignable cause of the performance breakage suture; therefore, the reported failure could not be evaluated.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident.

• Brand Name: PDS+ VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8290136
• Report Number: 2210968-2019-78636
• Device Sequence Number: 13951045
• Product Code: NEW
• UDI-Device Identifier: 10705031048126
• UDI-Public: 10705031048126
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061037
• 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): 01/08/2019

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: 05/31/2020
• Device Catalogue Number: PDP346H
• Device Lot Number: MGZ523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/20/2019
• Patient Sequence Number: 1