MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 1 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8425H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(4).Attempts are being 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.* what was the initial procedure? * could you please confirm if the issue (pull off) occurred before the procedure or during the procedure? * if it occurred before the procedure could you please clarify if the suture was found separate from needle in the package? * what is the lot number? * could you please confirm device's availability? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and suture was used.The suture was cut in union with the needle.There were no adverse patient consequences reported.

• Brand Name: PROLENE SUT 30IN(75CM) 1 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: 10950812
• Report Number: 2210968-2020-09606
• Device Sequence Number: 14257209
• Product Code: GAW
• UDI-Device Identifier: 10705031015470
• UDI-Public: 10705031015470
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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 Model Number: 8425H
• Device Catalogue Number: 8425H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/05/2020
• Patient Sequence Number: 1