MAUDE Adverse Event Report: ETHICON INC. CATGUT CHROM 75CM M3.5; SUTURE, ABSORBABLE, NATURAL

Catalog Number W44801

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Event Description

It was reported that during an unknown procedure suture was used.During the procedure needle and suture separated easily.There were no consequences to the patient.

Manufacturer Narrative

The actual sample has not been received for analysis.Retained 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.From the above analysis, it is evident that there was no issue related to the suture quality and processing of this incident lot.

Manufacturer Narrative

Product complaint # : (b)(4).A failed suture needle was submitted for fractographic evaluation.A fracture was observed in the body of the sample and was received in two pieces.Only one of the mating fracture surfaces was examined for this evaluation, the mating fracture surface was not provided for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of both microvoid coalescence, which is evidence of a ductile overload failure and intragranular, which is evidence of a brittle failure.This was a mixed mode fracture.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: CATGUT CHROM 75CM M3.5
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC - AURANGABAD; 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: 7359394
• MDR Text Key: 103146706
• Report Number: 2210968-2018-71589
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: W44801
• Device Lot Number: VE405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 05/24/2018
• Supplement Dates FDA Received: 05/15/2018; 06/01/2018
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1