MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; KIT CATH CENT VENOUS 3 LUM 16CM

Model Number	IPN036440
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The guidewire from the included aarow cvc kit completely unwound during deployment leading to loose wire attempting to enter the patient's bloodstream.Er doctor was able to remove and retrieve the wire but this could have been a catastrophic event.

• Brand Name: ARROW
• Common Device Name: KIT CATH CENT VENOUS 3 LUM 16CM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville rd; reading PA 19605 9607
• MDR Report Key: 11852200
• Report Number: 3014527682-2021-00005
• Device Sequence Number: 3565682
• Product Code: FOZ
• UDI-Device Identifier: 20801902117087
• UDI-Public: 20801902117087
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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 Model Number: IPN036440
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 23F20D0107,23F20H0151,13F21A00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1