MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 18IN 5-0 S/A P-3 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR493
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).Attempts have been 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.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.Did the needle pull off the suture thread? if no, explain the device issue.When did the device issue occur? in the packaging, during dispensing (before use on patient) or actual suturing (use on patient)? how was the case completed? any adverse patient consequences and what medical/surgical intervention was provided to manage them?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2019 and suture was used.The sutures separating easily.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/15/2020.Additional information: d4, d10, h4, h6.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances were identified.H3 device evaluation summary: it was received for analysis an opened box with three empty opened foil and seven unopened samples of product code vr493, lot ak8273.The complaint sample was not returned for analysis.During the visual inspection of seven unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.The following information was requested, but unavailable: did the needle pull off the suture thread? if no, explain the device issue.When did the device issue occur? in the packaging, during dispensing (before use on patient) or actual suturing (use on patient)? how was the case completed? any adverse patient consequences and what medical/surgical intervention was provided to manage them?.

• Brand Name: VCL RAP UD 18IN 5-0 S/A P-3 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9468122
• Report Number: 2210968-2019-90895
• Device Sequence Number: 3103505
• Product Code: GAM
• UDI-Device Identifier: 10705031134676
• UDI-Public: 10705031134676
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033746
• 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): 11/22/2019

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: 06/30/2023
• Device Catalogue Number: VR493
• Device Lot Number: AK8273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1