MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y496G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.At the end of the surgery, at the time that the suture began, there was the needle pull off.Needle was retrieved from the patient.There was no adverse event to the patient.No further information will be provided.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 4-0 UND
• 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.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7268961
• MDR Text Key: 100134494
• Report Number: 2210968-2018-70853
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059375
• UDI-Public: 10705031059375
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/01/2018

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: 10/31/2022
• Device Catalogue Number: Y496G
• Device Lot Number: AJ8609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/13/2018
• Date Device Manufactured: 12/04/2017
• 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