MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J426H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Summary: unopened samples were received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent a lap cholecystectomy procedure in 2019 and the suture was used.During use the needle popped off when suturing.There were no patient consequences reported.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8999108
• Report Number: 2210968-2019-87062
• Device Sequence Number: 3132842
• Product Code: GAM
• UDI-Device Identifier: 10705031039773
• UDI-Public: 10705031039773
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: J426H
• Device Lot Number: PCM415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention