MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN MEGAFINE NEEDLE 2IN; E-Z CLEAN MEGAFINE NEEDLE 2 INCH

Catalog Number	0118
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when preparing the supplies for personal pharmacy surgery, it is noticed that device tip has its secondary packaging defective losing the sterilization.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent 7/9/2024.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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, 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 Manufacturer Narrative
(b)(4).Date sent 2/20/2025.Corrected data d4: udi#.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.

• Brand Name: E-Z CLEAN MEGAFINE NEEDLE 2IN
• Common Device Name: E-Z CLEAN MEGAFINE NEEDLE 2 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY INDEPENDENCIA; chihuahua ; MX
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19700480
• Report Number: 3005075853-2024-04949
• Device Sequence Number: 17047962
• Product Code: GEI
• UDI-Device Identifier: 10614559101278
• UDI-Public: (01)10614559101278(17)290131(10)UBMDUB(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K081791
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 0118
• Device Lot Number: UBMDUB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown