MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK 4-0 45CM (1)SC-24; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1129T

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint (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.

Event Description

It was reported that the patient underwent a mammoplasty reduction procedure on (b)(6) 2020 and the suture was used.It was reported that when opening the envelope, it tears, preventing the correct opening and contaminating the internal product, the thread opening is tearing and does not expose the product.

Manufacturer Narrative

(b)(4).Date sent to the fda: 03/11/2020.Additional information: the sample is to be sent by the customer.A manufacturing record evaluation was performed for the finished device lot am3121, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/17/2020.Additional information: additional h3 investigation summary: it was received for analysis two samples of product code 1129t, lot am3121.During the visual inspection of the representatives samples, the paper of overwrap packets were observed delaminated.A functional test was performed to the packet and the seal strength force met the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the condition of the samples, the assignable cause of the packaging integrity is caused by delamination.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9711187
• MDR Text Key: 196287503
• Report Number: 2210968-2020-01188
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1129T
• Device Lot Number: AM3121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/03/2020
• Patient Sequence Number: 1