MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Catalog Number	EFX002
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "metal flaking".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was not returned to the manufacturer for evaluation.The manufacturer reported: "a review of the unit's dhr could not be performed as no lot number was provided.A review of the device could not be performed as it was not returned to paragon medical nor were any images provided.Additionally, it is unclear what the nature of the failure mode noted above (metal flaking) is as it has never been observed by paragon medical nor has been previously reported.Therefore, this complaint is considered unverified and invalid." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
The report states "metal flaking".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17389283
• Report Number: 3011137372-2023-00198
• Device Sequence Number: 17109633
• Product Code: HCF
• UDI-Device Identifier: 14026704739001
• UDI-Public: 14026704739001
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Catalogue Number: EFX002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown