MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J467H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pam609 batch number, and no non-conformance were identified.Attempts are being made to retrieve the device.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 unknown procedure on an unknown date and suture was used.The suture was detached from the needle during continuous suturing.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: a detached needle and a labeled winding former with a suture of product code j467, lot # pam609 were received for evaluation.During the visual inspection of the sample, the swage and attachment area of the detached needle were noted to be as expected.The barrel hole was examined under 20x magnification and remnant suture was noted, the suture end is severely cut (damaged), resulting in a clip off defect.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition and the assignable cause of the pull off - suture needle is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking and due to this condition.

• Brand Name: VCL CT BRD VIO 27IN 0 S/A CP-1
• 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: 9098803
• Report Number: 2210968-2019-87945
• Device Sequence Number: 14117472
• Product Code: GAM
• UDI-Device Identifier: 10705031040199
• UDI-Public: 10705031040199
• 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,Followup
• Report Date (Section B): 08/27/2019

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: 12/31/2023
• Device Catalogue Number: J467H
• Device Lot Number: PAM609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1