MAUDE Adverse Event Report: LAKE REGION MEDICAL STARTER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	42175
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that foreign matter was identified inside the package.This starter guidewire was selected for preparation, however, upon opening a hair was found inside the package.
Additional Manufacturer Narrative
B3 date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that foreign matter was identified inside the package.This starter guidewire was selected for preparation, however, upon opening a hair was found inside the package.It as further reported that this medical device report was created and submitted in error as this product is externally manufactured by lake region medical.The external manufacturer holds reporting responsibilities for this product.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway ; EI
• MDR Report Key: 12094105
• Report Number: 2134265-2021-08339
• Device Sequence Number: 4218602
• Product Code: DQX
• UDI-Device Identifier: 08714729327028
• UDI-Public: 08714729327028
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 11/30/2023
• Device Model Number: 42175
• Device Catalogue Number: 42175
• Device Lot Number: 0005999685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1