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

Catalog Number	PDP371T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
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.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: mg5308.
Event or Problem Description
It was reported that a patient underwent an unknown abdominal procedure on unknown date in (b)(6) 2019 and suture was used.The suture loosened from the needle during use.Another device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information: device identification, concomitant medical products, device evaluated by mfr, device manufacture date, evaluation codes.Device evaluation summary: one empty opened box and eight unopened samples of product code pdp371, lot # mg5308 were returned for analysis.The complaint sample was not received.During the visual inspection of eight 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 strands and no defects were observed.A functional test was performed 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 performance pull off suture needle was found, and the tested samples met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number mg5308, and no non-conformances were identified.

• Brand Name: PDS+ VIO 36IN 1 S/A CTX
• 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: 8791392
• Report Number: 2210968-2019-84296
• Device Sequence Number: 1845594
• Product Code: NEW
• UDI-Device Identifier: 10705031048201
• UDI-Public: 10705031048201
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 06/19/2019

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: PDP371T
• Device Lot Number: MG5308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/12/2019
• Patient Sequence Number: 1