MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J497H
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2019 and suture was used.During the procedure, the suture falls apart when pulled from package for use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Two open samples and three unopened samples of product code j497, lot # pgz908 were returned for analysis.During the visual inspection of five samples (two open and three unopened) no needle pull off was noted since the needle was attached to suture, but severe damage on the suture could be observed and due to this condition, a functional test was performed and the tensile strength force was below the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, the assignable cause of the pull off ¿ suture needle is a damaged suture.In addition, fifteen unopened samples of product code j497, lot # pgz908 were returned for analysis.During the visual inspection of fifteen 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 suture needle pull off was found, and the tested sample met the finished goods requirements.

• Brand Name: VCL CT BRD UD 18IN 3-0 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
• MDR Report Key: 9405793
• Report Number: 2210968-2019-90461
• Device Sequence Number: 2877277
• Product Code: GAM
• UDI-Device Identifier: 10705031040632
• UDI-Public: 10705031040632
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 05/31/2024
• Device Catalogue Number: J497H
• Device Lot Number: PGZ908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/24/2019
• Patient Sequence Number: 1