MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK 6-0 45CM (1)SC-20; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 14500T

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018, and suture was used.Prior to use, it was noted that the packaging was damaged.There were no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 01/08/2019.Investigation summary: it was reported packaging integrity.An unopened sample of was returned for analysis.During the visual inspection of the overwrap packet, suture material in the seal area was noted in the packet, compromising the sterile barrier.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the packaging integrity is a suture in the seal.Two pictures of the sample were received for analysis.Upon visual inspection of the pictures, an overwrap packet was with a suture in seal could be observed.Per the condition observed on the pictures, the assignable cause of the packaging integrity is a suture in the seal.

• 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: 8147873
• MDR Text Key: 129910478
• Report Number: 2210968-2018-77630
• 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
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 14500T
• Device Lot Number: AK9406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 12/12/2018
• Patient Sequence Number: 1