MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 2-0 S/A CTB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	JB839
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot phm038, 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 a patient underwent an unknown procedure on (b)(6) 2019; and a suture was used.During the procedure, the suture pulled off the needle.It was a control release needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 8X18IN 2-0 S/A CTB-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9982195
• Report Number: 2210968-2020-03290
• Device Sequence Number: 19355983
• Product Code: GAM
• UDI-Device Identifier: 10705031044012
• UDI-Public: 10705031044012
• 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): 03/30/2020

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 Expiration Date: 06/30/2024
• Device Model Number: JB839
• Device Catalogue Number: JB839
• Device Lot Number: PHM038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1