MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number PXX52

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

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.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on the patient, the needle had been found punctured out of the package which the package was not sterile.There were no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

Product complaint #(b)(4).Date sent to the fda: 07/13/2020 additional information: d4, d10, h4 h3 evaluation: an unopened sample of product was returned for analysis.The product is multi-strand and contains ten strands double armed per packet.During the visual inspection of the sample, the sterile barrier was compromised due to pin hole on the copolymer and top of msda folder.The sample was opened, it was noted that the needle was orientated vertically in the package and this caused the hole on cavity.The manufacturing records were reviewed and the manufacturing / packaging criteria were prior to the release of this batch.Based on the samples condition, the assignable cause of packaging integrity, suggests an incorrect needle park resulting in a pin hole on package.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, 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.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10133054
• MDR Text Key: 194500039
• Report Number: 2210968-2020-04430
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 10705031049338
• UDI-Public: 10705031049338
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: PXX52
• Device Catalogue Number: PXX52
• Device Lot Number: PCM460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1