MAUDE Adverse Event Report: ETHICON INC. MONOCRYL VIO 27IN USP6-0::S/A P-1 PRIME; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y490H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that the patient underwent an unknown procedure in 2018 and suture was used.During the procedure, the needle came off suture when pulled through tissue.There were no patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Unopened samples of product were 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.A functional test was performed for the pull force and all were above the minimum requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no attachment defects were found and the tested samples met the finished goods requirements,.

• Brand Name: MONOCRYL VIO 27IN USP6-0::S/A P-1 PRIME
• 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.JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7472446
• MDR Text Key: 106874564
• Report Number: 2210968-2018-72446
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/05/2018

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: 05/31/2022
• Device Catalogue Number: Y490H
• Device Lot Number: LGZ976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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