MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP489G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Trade name: (b)(4), active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: 2360 g/m.
Event or Problem Description
It was reported that a patient underwent a hypospadias procedure on (b)(6) 2021 and suture was to be used.During the procedure, when the suture was removed from package, it was found that a double armed suture was inside when it was supposed to be a single.Another like device was used to complete the procedure.No adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Pc(b)(4).Date sent to the fda: 9/21/2021.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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.A manufacturing record evaluation was performed for the finished device lot number qpmatz and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: visual analysis of the returned product revealed that one opened sample of product code mcp489 was received to ethicon inc for evaluation and an extra needle/suture combination of the same product code was observed.The product code should contain a strand single armed.The wrong number of strands observed during the visual assessment has been correlated to the manufacturing process.Based on the information currently available, the extra needle was identified during the investigation of the sample received.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 g/m.

• Brand Name: MCRYL+ UD 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12360521
• Report Number: 2210968-2021-07635
• Device Sequence Number: 17077611
• Product Code: GAM
• UDI-Device Identifier: 10705031046535
• UDI-Public: 10705031046535
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 11/30/2024
• Device Model Number: MCP489G
• Device Catalogue Number: MCP489G
• Device Lot Number: QPMATZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1