MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8746
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that a patient underwent a coronary artery bypass graft procedure on an unknown date and suture was used.During the procedure, the doctor removed the needle from the packet and the needle was a larger diameter than what the doctor expected.The doctor continued to use the same needle to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary an empty opened overwrap and a folder with two needle /suture combinations of product code (b)(4), lot lkb944 were received for analysis.This product code is multi strand and double armed.During the visual inspection of the sample, no defects were found on the package.The swage and attachment area of the needles were as expected.The needles was comparison on the needle drawing specification and the needle fall inside shadow lines.Also,the needle was measured in needle diameter, point type, needle type, and the sample met the requirements for to tapper point (b)(4) and is correct for the product code (b)(4).In addition, no damage, defects or anomalies on the needle could be observed.According to condition of the sample received the tips of the needles meet the ethicon needles specification and no incorrect component was noted.

• Brand Name: PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU
• 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: 7565698
• Report Number: 2210968-2018-73271
• Device Sequence Number: 13948207
• Product Code: GAW
• UDI-Device Identifier: 10705031203686
• UDI-Public: 10705031203686
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: EPM8746
• Device Lot Number: LKB944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1