MAUDE Adverse Event Report: ETHICON INC. MONOCRYL ABS SUR SUT SYN; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number NW1326

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the patient underwent c-section procedure on (b)(6) 2018 and suture was used.During the procedure, the suture and the needle got separated.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Five retain samples of incident code and lot number were retrieved for analysis.The primary 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 primary packs were opened and sutures and needles were found intact.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.The retain samples were tested for knot pull tensile strength & needle pull test and found to meet the specification.As a part of further investigation batch manufacturing record was reviewed.The batch manufacturing record was reviewed for any process deviation but no deviation was observed.Finished good record was reviewed and found to meet the specification.It is evident that there was no issue related to the suture quality and processing of this incident lot.As the complaint is related to performance ¿ pull off suture needle, needle pull-off test is applicable & measurable parameter.Needle pull-off test was performed over five retain samples to check the behavior of the swaging process.The average needle pull value of the retain sample was found to meet the average usp requirement.

• Brand Name: MONOCRYL ABS SUR SUT SYN
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-AURANGABAD; 312379@b-15/1; m.i.d.c., 1 walu; aurangabad ; IN
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7430292
• MDR Text Key: 106019843
• Report Number: 2210968-2018-72138
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: NW1326
• Device Lot Number: T4038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 05/19/2018
• Supplement Dates FDA Received: 05/21/2018
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1