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

Catalog Number	PXX50
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7823427
• Report Number: 2210968-2018-75467
• Device Sequence Number: 1116926
• Product Code: GAT
• UDI-Device Identifier: 10705031049321
• UDI-Public: 10705031049321
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/28/2018
• Patient Sequence Number: 1