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

Model Number	J503G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.What was the initial procedure? what is the event day and procedure date? could you please confirm if there were any patient consequence due to the pull off suture needle? 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 needle and suture separated.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/6/2021 additional information: d4, d9, h4, h6 the following information was requested, but unavailable: - what was the initial procedure? - what is the event day and procedure date? -could you please confirm if there were any patient consequence due to the pull off suture needle? h3 evaluation: an empty opened foil and a dispensed suture of product were received for evaluation.During the visual inspection of the dispensed suture, the ends were examined under magnification and the swage area could not be observed, the second ends were found with marks and damaged, the needle was not received for evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as opened sample on what caused the needle and thread separation.  this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10785134
• Report Number: 2210968-2020-08655
• Device Sequence Number: 4135628
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 12/31/2024
• Device Model Number: J503G
• Device Catalogue Number: J503G
• Device Lot Number: QAMJEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1