MAUDE Adverse Event Report: ETHICON INC. MONOCRYL 2/0 70CM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number NW1602

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

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 during an c section procedure, suture was used.While suturing subcutaneous layer the needle & suture were separated.There were no consequences to the patient.

Manufacturer Narrative

We received 1 opened complaint sample zipper tray, lid along with suture for lot t7005.Suture material was inspected under 10 x magnification and suture found in partially disintegrated condition.As the complaint sample received in open condition further investigation on complaint sample cannot be performed except visual inspection.The mentioned complaint sample foil pack was not returned for investigation.Needle was not returned for investigation.Five retain samples of incident codes and lot number was retrieved for analysis.The primary packs of the retained samples were visually inspected and no defects were observed.The primary packs were opened and sutures and needles were found intact.The sutures and needles were physically inspected for any attribute defects and no defects were observed.The retained samples were tested for knot pull tensile strength & needle pull test and found to meet the specification.

• Brand Name: MONOCRYL 2/0 70CM
• 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 INDIA; 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: 7415545
• MDR Text Key: 105379204
• Report Number: 2210968-2018-72057
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K960653
• 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: 03/20/2018

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: 06/30/2022
• Device Catalogue Number: NW1602
• Device Lot Number: T7005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/02/2018
• Date Device Manufactured: 07/01/2017
• 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