MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J532H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The reported product code for this complaint is j532h.The lot reported of pd2802 is related to product code vcp422h.Please provide the correct lot number.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the needle pulled off the suture.Changed another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 1/7/2020.Additional information has been requested, and the following was obtained: the reported product code for this complaint is j532h.The lot reported of pd2802 is related to product code vcp422h.Please provide the correct lot number.Unobtainable.

• Brand Name: VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-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: 9384040
• Report Number: 2210968-2019-90358
• Device Sequence Number: 19387988
• Product Code: GAM
• UDI-Device Identifier: 10705031040984
• UDI-Public: 10705031040984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/11/2019

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 Catalogue Number: J532H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1