MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 30IN 4-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	9706H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: how much blood was loss?*how was the bleeding managed? not sure exactly, but less than 100cc.Managed by additional suture.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No.What's the patient current status? unknown.
Event or Problem Description
It was reported that a patient underwent a whipple procedure on (b)(6) 2019 and the suture was used.It was reported that during surgery, while performing the vascular anastomosis, the needle fractured in half near the swage, creating needle hole bleeding at the vessel site.The doctor was able to retrieve the needle pieces.The procedure was completed using a like device from another lot.It was also reported that the procedure was delayed by thirty minutes.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE HS BLU 30IN 4-0 D/A C-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9372495
• Report Number: 2210968-2019-90299
• Device Sequence Number: 14097893
• Product Code: GAW
• UDI-Device Identifier: 10705031022881
• UDI-Public: 10705031022881
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 05/31/2023
• Device Catalogue Number: 9706H
• Device Lot Number: MGQ459
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1