MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 6-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J212H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) batch number, and no non-conformances were identified.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 pyeloplasty procedure on (b)(6) 2019 and suture was used.The suture was fraying and cutting through the tissue like barbs.It is unknown what was used to complete the procedure successfully.There were no adverse patient consequences reported.

• Brand Name: VCL CT BRD UD 27IN 6-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9401441
• Report Number: 2210968-2019-90431
• Device Sequence Number: 1711346
• Product Code: GAM
• UDI-Device Identifier: 10705031038196
• UDI-Public: 10705031038196
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 10/31/2023
• Device Catalogue Number: J212H
• Device Lot Number: MM6938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1