MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 12"(30CM) 5-0 WHT; : INSTRUMENT, SURGICAL, DISPOSABLE

Catalog Number RS22

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that a patient underwent a cervical cerclage procedure on (b)(6) 2018 and suture was used.The thread pulled out from needle swaging while pulling thread to outside of the suture area.The needle remained intact.The tension of knot was satisfactory to the surgeon; the needle was set aside, a new suture and needle was obtained.Needle was noted to be intact.Restarted suturing and completed procedure with new suture.The patient was not adversely affected by the incident.

Manufacturer Narrative

Product complaint # pc-(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.

• Brand Name: MERSILENE SUTURE 12"(30CM) 5-0 WHT
• Type of Device: : INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7335546
• MDR Text Key: 102330476
• Report Number: 2210968-2018-71407
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: RS22
• Device Lot Number: GLB200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2018
• Date Device Manufactured: 10/02/2013
• 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