MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 40IN 1 S/A CT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 4999G

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Evaluation: only a photo of the sample was received for analysis to date.Upon visual inspection of the picture, a sample of product code 4999 lot# par570 could be observed.The product code requires an ethilon black suture and a taper point needle.However as the sample was not returned and the picture is not colored, no conclusion could be reached.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to obtain the device.To date the device has not been returned and no additional information has been received.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The product package was opened and the suture material different to what is supposed to be in package.No reported patient consequences.

Manufacturer Narrative

(b)(4).Date sent to the fda: 09/06/2019.A manufacturing record evaluation was performed for the finished device lot number par570, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: an opened sample of product code 4999, lot par570 was returned for analysis.During visual inspection of the sample, a partially dispensed green suture (braided) with a cutting-edge needle could be observed into a paper folder; however, this mismatched with the print description on the foil for product code 4999 that required an ethilon black suture (monofilament) and a taper point needle.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample received, the reported complaint is assembly product mix / incorrect component.

• Brand Name: ETHLN BLK 40IN 1 S/A CT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8871000
• MDR Text Key: 153662008
• Report Number: 2210968-2019-85275
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 4999G
• Device Lot Number: PAR570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 08/12/2019
• Patient Sequence Number: 1