MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 DA V-5 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number PXX50

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported a patient underwent a mitral valve replacement on (b)(6) 2018 where suture was used.After placing the sutures, the doctor found a pledget from one of the sutures that was thicker than the other sutures in the line, looking 50% thicker than the surrounding pledgets.The suture with the thicker pledget was used in the procedure.The procedure was completed with no consequence to the patient.

Manufacturer Narrative

Product complaint #: (b)(4).A representative sample was returned for evaluation.During the visual inspection of the sample, no defects were found on the overwrap package.The sample was opened and contains eight needle-suture combinations with a pledge threading each into msda folder.The winding of strands was correct; however, in the inspection of the pledgets were noted that the rectangular shape of pledgets had lost on three samples, since it was bent and this caused that the pledgets, looking thicker than the others.No incorrect component was observed.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 the assignable cause is bending pledgets.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 DA V-5 8PLGT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7823427
• MDR Text Key: 118546818
• Report Number: 2210968-2018-75467
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 10705031049321
• UDI-Public: 10705031049321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: PXX50
• Device Lot Number: LKZ585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1