MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 30IN 5-0 D/A RB-2 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPH8710H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Attempts are being made to receive a device for evaluation.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a cardiac surgery on (b)(6) 2020 and the suture was used.It was reported that the problem of pulling off suture needle happened when the suture was drawn close to sew for the seventh to the eighth stitches during the procedure.Another like suture was used to complete the surgery.There was no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/17/2020.A manufacturing record evaluation was performed for the finished device lot number pkh033, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: a needle/suture piece of product code eph8710, lot # pkh033 were returned for evaluation.During the visual inspection of a needle/suture piece, the swage and attachment area were noted to be as expected and a suture piece was noted still attached to needle and the end was noted cut appears to be by use of a surgical instrument.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.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 received, no performance - pull off suture needle was noted and the suture was damaged by an improper handling.

• Brand Name: PRLNE HS BLU 30IN 5-0 D/A RB-2 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10111664
• Report Number: 2210968-2020-04300
• Device Sequence Number: 11716659
• Product Code: GAW
• UDI-Device Identifier: 10705031233485
• UDI-Public: 10705031233485
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: No Information
• Device Expiration Date: 07/31/2024
• Device Model Number: EPH8710H
• Device Catalogue Number: EPH8710H
• Device Lot Number: PJJ997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/17/2020
• Patient Sequence Number: 1