MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 18IN(45CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8684G
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 an unknown procedure on an unknown date and suture was used.It was noted that the suture needle protruding from the packet.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/22/2020.Additional information: h6.A manufacturing record evaluation was performed for the finished device batch kgq502, 8684g35 and no non-conformances were identified.

• Brand Name: PROLENE SUT 18IN(45CM) 3-0 BLU
• 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: 9395997
• Report Number: 2210968-2019-90373
• Device Sequence Number: 2594042
• Product Code: GAW
• UDI-Device Identifier: 10705031018945
• UDI-Public: 10705031018945
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/12/2019

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: 05/31/2021
• Device Model Number: 8684G
• Device Catalogue Number: 8684G
• Device Lot Number: KGQ502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/01/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1