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

Model Number	MCP493G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was provided: source of information: obtained from the initial reporter on dd mmm yyyy or provided from knowledge as you were present in the case? nicole: i was not present in the case hence it was the feedback from the nurse.Is there evidence that could suggest that the reported suture was part of a product mix in the package? nicole: i¿m unsure for this aspect as i was not in the case, the nurse mentioned that she saw the double arm when she open the suture package.Attempts are being 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.H6 component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Trade name - irgacare®.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 urology procedure on (b)(6) 2023 and suture was used.The scrub nurse opened 1 packet and realized it was a double arm instead of a single needle.The needle was not used on the patient.The procedure was successfully completed with no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/28/2023.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.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample determined that it was received, one open that pertain to the product code mcp493g.The product code required one strand single armed per packet.Upon visual inspection of the returned sample, it was observed a partially dispensed needle suture that appears to be double-armed.The suture was dispensed, and it was found two strands single-armed into the winding former, resulting in a wrong number of components in the package.In addition, no product mix was noted during the evaluation.Based on the information currently available, the extra needle issue was identified as wrong number of components during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc 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.H3 photo investigation summary: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows an open foil package, with a winding former for product code mcp493g, a double armed sample dispensed.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MCRYL+ UD 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16954016
• Report Number: 2210968-2023-03656
• Device Sequence Number: 6916326
• Product Code: GAM
• UDI-Device Identifier: 10705031046566
• UDI-Public: 10705031046566
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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: 08/31/2024
• Device Model Number: MCP493G
• Device Catalogue Number: MCP493G
• Device Lot Number: SKMQAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 06/15/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown