MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A P-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J503G
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).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 on an unknown date and suture was used.During the procedure, the suture separated from the needle.Another like device was used.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A paper lid and a winding former with an un-dispensed suture of product code j503 were returned for analysis.During the visual inspection of the sample, the suture end presents a correct impression of the swage area and enough insertion, however the suture was trapped in a door of the relay tray and due to this condition, the needle was pull off the suture.The manufacturing records couldn't be reviewed as the batch number is unknown.According the sample conditions, the assignable cause of the performance pull off - suture needle, was caused by trapped suture.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A P-2 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: 9198521
• Report Number: 2210968-2019-88735
• Device Sequence Number: 16908593
• Product Code: GAM
• UDI-Device Identifier: 10705031040717
• UDI-Public: 10705031040717
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/21/2019

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 Catalogue Number: J503G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 09/21/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/12/2019
• Patient Sequence Number: 1