MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP333H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 a gall bladder procedure on (b)(6) 2018 and suture was used.The suture snapped away from the needle when closing the umbilicus.A different suture was used to complete the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/16/2018.Evaluation: a top foil, a paper lid, a winding former and a needle/suture piece returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The barrel hole was examined under magnification for suture remnant and still had attached a suture piece to barrel hole.No needle pull off could be observed.The suture piece was examined and the end present elongation and the end appeared to be damaged (dent) by the use of a surgical instrument.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, no needle suture pull off was observed.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-2
• 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: 7773585
• Report Number: 2210968-2018-75070
• Device Sequence Number: 1012378
• Product Code: NEW
• UDI-Device Identifier: 10705031048065
• UDI-Public: 10705031048065
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 07/19/2018

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: 11/30/2019
• Device Catalogue Number: PDP333H
• Device Lot Number: LPZ330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 12/16/2018
• Patient Sequence Number: 1