MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 30CMX5MM D/A CTX; INSTRUMENT, SURGICAL, DISPOSABLE

Catalog Number RS22

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2018

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 a patient underwent a cerclage procedure on (b)(6) 2018 and suture was used.During the procedure, the needle detached in the cervix.It didn't fall inside of patient.Changed new one to complete.There was no adverse patient consequences reported.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Two detached needles and mersilene tape suture were returned for analysis.The product code is double armed.During the visual inspection of two needles, the swage and attachment area were as expected.The barrel hole of needles was examined under 20x magnification for suture remnant and none was noted.Additionally, there are marks on body needles that appears to be by use of surgical instrument.The suture ends were examined and there isn¿t sufficient impression at the swage end, resulting in the needle pull off.Per the condition of the sample received, the assignable cause of the performance pull off suture needle is a light swage defect, this defect is caused when does not tightens the press correctly and the swage area be weak on the needle/suture.

• Brand Name: MERS TAPE WHT 30CMX5MM D/A CTX
• 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 PR; 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: 7743428
• MDR Text Key: 115908391
• Report Number: 2210968-2018-74844
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: RS22
• Device Lot Number: LLB964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1