MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB947H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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: could you please confirm how did you get this device? the hospital purchased the interceed kit (product code: ickit20) from jjkk.The product (vcpb947h) had been included in the kit.Could you please confirm if this is a johnson & johnson's device? yes.Is there any photo available for analysis? no photos are available.
Event or Problem Description
It was reported that a patient underwent an unknown surgery procedure on (b)(6) 2020 and suture was used.The suture was detached from the needle.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VCL+ UD 36IN 1 S/A CTB-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: 10370249
• Report Number: 2210968-2020-05891
• Device Sequence Number: 804424
• Product Code: GAM
• UDI-Device Identifier: 10705031056749
• UDI-Public: 10705031056749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• 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): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VCPB947H
• Device Catalogue Number: VCPB947H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/05/2020
• Patient Sequence Number: 1