MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X36IN 3-0 D/A SH 4PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D9066
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: product code: d9060 changed to d9066.The following information was requested, but unavailable: please provide the lot number for the involved device.No further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on (b)(6) 2021 and suture was used.During the procedure, it was found that the length of the suture with the pledget was too short, so it could not be used.No adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 4X36IN 3-0 D/A SH 4PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11964782
• Report Number: 2210968-2021-05379
• Device Sequence Number: 4354060
• Product Code: GAW
• UDI-Device Identifier: 10705031031944
• UDI-Public: 10705031031944
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: D9066
• Device Catalogue Number: D9066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1