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	Not Applicable (3189)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a pancreaticoduodenectomy procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture pulled off the needle.The needle fell inside of patient, and finally it was retrieved through ct.Another like device was used to complete the procedure.Surgery was delayed for about 30 to 40 minutes.There were no adverse patient consequences reported.The patient is stable now.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 06/30/2020.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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: 9995159
• Report Number: 2210968-2020-03452
• Device Sequence Number: 14563498
• 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): 04/19/2020

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: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: EPH8710H
• Device Catalogue Number: EPH8710H
• Device Lot Number: PPBEXB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1