MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y923H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported from suture was used during a veterinarian procedure.During the procedure, the thread pulled off from needle.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

An opened box with unopened samples of product code were sent for analysis.The issue sample was not returned for evaluation.During the visual inspection of samples, no defects were found on the packages.The samples were opened and the swage and attachment area of the needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.The samples were tested by needle pull and met the finished goods requirements.Per the conditions of the samples received, no attachment defects were found and the tested samples met the finished goods requirements.

• Brand Name: MCRYL VIO 36IN 3-0 S/A FS-2
• 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.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7415633
• MDR Text Key: 105377952
• Report Number: 2210968-2018-72058
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059863
• UDI-Public: 10705031059863
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 09/30/2022
• Device Catalogue Number: Y923H
• Device Lot Number: LLZ172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• 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: 04/05/2018; 05/03/2018
• Supplement Dates FDA Received: 04/30/2018; 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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