MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number NW3321

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The doctor opened suture from a box labeled size 3-0, but the actual size of the suture inside the foil was size 4-0.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Batch manufacturing records of nw3321/ b9005 was reviewed for any process deviation but no deviation was observed.Additional summary: 10 representative samples were received in intact condition.During visual evaluation, received products were found genuine.These samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack but no such defects were observed.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were also inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed in received samples.Five retain samples of the incident code and lot number were also retrieved for analysis.These packs of retain samples were visually inspected for attribute defects like pseudo seal, pin hole, product in seal, press marks on pack but no such defects were observed.The sutures were physically inspected for any attribute defects like kinks, weak spots, broken piece, fray, brittleness, detached needles but no such defects were observed.The needles were inspected for any attribute defects like bend, cracked barrel, fins but no such defects were observed.Finished goods record was reviewed for fg release parameters like diameter, tensile strength, needle pull value & extractable color at release and was found to meet the specification.From the above analysis it is evident that there was no issue related to the suture quality and processing of this incident lot.All the individual/average diameter values for representative complaint & retain samples were found meeting usp individual/average diameter specification requirement.This analysis shows that there was no issue related to processing of the lot.All the values are within the control limits.Based on the analysis this is not a confirmed complaint.

• Brand Name: ETHILON NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9225258
• MDR Text Key: 194450248
• Report Number: 2210968-2019-88976
• 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: 09/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: NW3321
• Device Lot Number: B9005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 10/21/2019
• Patient Sequence Number: 1