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

Catalog Number Y494G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: was the outer box damaged or the primary package damaged? customer does not recall any box damage.How many devices were found detached when the suture packets were opened? one package opened with just a needle, no suture.How many devices experienced suture needle pull off during use? a 2-3 pulled off during use.Is the lot number available? llk581.

Event Description

It was reported by distributor that patient underwent unknown procedure on (b)(6) 2018 and suture was used.The needle separated from the suture during use.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint #
=
> (b)(4) the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.

• 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.; 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: 7470118
• MDR Text Key: 106872802
• Report Number: 2210968-2018-72408
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2018

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: Y494G
• Device Lot Number: LLK581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 06/01/2018
• Supplement Dates FDA Received: 04/30/2018; 06/01/2018
• Date Device Manufactured: 10/30/2017
• 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