MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN USP0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z2017H

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Device return status/follow up? please clarify a product code and valid lot number involved in this event as lot number pju334 corresponding not to reported pds suture product code z2017?.

Event Description

It was reported that the patient underwent an unknown procedure in 2019 and the suture was used.The needle detached.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 03/04/2020.Additional information: d4, d10, h4, h6: a manufacturing record evaluation was performed for the finished device lot number pju344, and no non-conformances were identified.Additional h3 investigation summary: one open box with unopened samples of product code z2017h, lot pju344 was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of the 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.Additional information was requested and the following was obtained: please clarify a product code and valid lot number involved in this event.The lot number & product code as provided by the customer.

• Brand Name: PDSII VIO 27IN USP0
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9528410
• MDR Text Key: 193649039
• Report Number: 2210968-2019-91374
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z2017H
• Device Lot Number: PJU344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1