MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN 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 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance pull off suture needle.It was received for analysis an empty opened overwrap, a foil with an empty folder, a detached needle and a needle suture.During visual inspection of the needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined along of the strand, a correct insertion mark was observed.However, the force used to detach needle from the suture could not be determined.Also, the other extreme of the needle-suture was examined and the swage and attachment area were noted to be as expected and a functional test was performed and the pull force 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 condition of the sample, it could not be determined what may have caused the reported incident of: ¿the problem of pulling off suture needle happened during the surgery¿.

Event Description

It was reported that a patient underwent a cervical cerclage on (b)(6) 2019 and suture was used.During the procedure, the needle pulled off the suture.Changed another one to complete the surgery.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/17/2019.It was reported performance pull off: suture needle.A picture was returned for analysis.Upon visual inspection of the photo, a needle/suture and a detached needle could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: MERS TAPE WHT 12INX3/16IN 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
• MDR Report Key: 8982789
• MDR Text Key: 157182165
• Report Number: 2210968-2019-86909
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: RS22
• Device Lot Number: MDH999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/23/2019
• Patient Sequence Number: 1