MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 0 S/A CTXB; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB978
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pc6478 batch number, and no non-conformances were identified.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 the patient underwent an ob-gyn procedure on an unknown date and suture was used.During use, the suture was broken easily.There were no adverse patient consequences reported.

• Brand Name: VCL CT BRD UD 36IN 0 S/A CTXB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9382879
• Report Number: 2210968-2019-90218
• Device Sequence Number: 2026325
• Product Code: GAM
• UDI-Device Identifier: 10705031044104
• UDI-Public: 10705031044104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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
• 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: 02/29/2024
• Device Catalogue Number: JB978
• Device Lot Number: PC6478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1