MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036439
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "guidewires were sticking and not going through or pulling out" the needle.It was reported the wire unraveled after becoming stuck inside of the needle.Additional information was requested but is not available at the time of the this report.
Event or Problem Description
The complaint is reported as: "guidewires were sticking and not going through or pulling out" the needle.It was reported the wire unraveled after becoming stuck inside of the needle.Additional information was requested but is not available at the time of the this report.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.The photos displayed a guide wire through an introducer needle.The guide wire appeared to be unraveled from the distal end.The distal j-tip of the core wire was visible in the photo.However, a full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of guide wire/needle resistance was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11507729
• Report Number: 9680794-2021-00094
• Device Sequence Number: 16848298
• Product Code: FOZ
• UDI-Device Identifier: 30801902117152
• UDI-Public: 30801902117152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN036439
• Device Catalogue Number: CDC-45703-1A
• Device Lot Number: 13F20H0267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1