MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J442H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested, and the following was obtained: * please confirm if a box of j442h was labeled incorrectly as j316h (labeling issue) or if sutures from j316h were found within a box of j442h (product mix/incorrect component).Box of j442h was labeled correctly.Packaged with j316h suture.Product mix/incorrect component.* please confirm if this is a delivery issue (ordered j442h and received j316h instead).Not a delivery issue.* were there any patient consequences? no patient consequences.It was noticed by an rn pulling a suture from the box.Upon further investigation, realized the whole box was filled with j316h instead of j442h.* please confirm lot tmmbc as it appears to be missing a number.Correction: tmmmbc a review of the batch manufacturing records was conducted, and no related non-conformances were identified.Investigation summary the product was returned to ethicon for evaluation.The returned product determined that one empty box of product code j442h with lot tmmmbc was received for evaluation.In addition, one open sample unused in a petri dish and thirty-four unopened samples loose that belong to product code j316h and lot tmbbgtz0 inside a plastic bag.Due to the mismatch observed, a further investigation was performed, and the following was observed: the empty box for product code j442h with lot tmmmbc was manufactured on nov/23/2023 and expired date oct/31/2028 at juarez, mx.The samples of product code j316h, lot tmbbgtz0 were manufactured in germany in nov/02/2023 and expiration on apr/30/2029.Also, according to the sampling plan, a visual inspection was performed on thirteen samples, and no anomalies or issues related to packaging integrity were observed during the evaluation.Based on the investigation performed, it was determined that the products returned were manufactured at different sites.Therefore, they could not have been mixed during the manufacturing process.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that patient underwent an unknown procedure on (b)(6)2024, and suture was used.They received a box of suture that was packed in the box labeled for a different product.Additional information has been requested.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19710893
• Report Number: 2210968-2024-07077
• Device Sequence Number: 8541335
• Product Code: GAM
• UDI-Device Identifier: 10705031039933
• UDI-Public: 10705031039933
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: J442H
• Device Lot Number: TMMMBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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