MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036440
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The mdr report key/report number is (b)(4).The mdr text key is (b)(4).
Event or Problem Description
Complaint found in maude database: "the left side the guidewire started to unravel with the tip still in the vein itself as i was trying to guide it into the vein while changing the angle of the needle in case i was hitting against the wall of the vein.I removed the introducer needle so that the guidewire was not snagged on the bevel of the needle and then tried to remove the guidewire.After some initial resistance i was able to get the guidewire out of the vein and verified that the tip had been removed.We kept the faulty guidewire so that the incident could be communicated to the manufacturer.".
Event or Problem Description
Complaint found in maude database: "the left side the guidewire started to unravel with the tip still in the vein itself as i was trying to guide it into the vein while changing the angle of the needle in case i was hitting against the wall of the vein.I removed the introducer needle so that the guidewire was not snagged on the bevel of the needle and then tried to remove the guidewire.After some initial resistance i was able to get the guidewire out of the vein and verified that the tip had been removed.We kept the faulty guidewire so that the incident could be communicated to the manufacturer.".
Additional Manufacturer Narrative
Qn#(b)(4).The mdr report key/report number is (b)(4).The mdr text key is (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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 PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11948265
• Report Number: 1036844-2021-00104
• Device Sequence Number: 1152837
• Product Code: FOZ
• UDI-Device Identifier: 20801902117087
• UDI-Public: 20801902117087
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 02/28/2022
• Device Model Number: IPN036440
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 23F20J0355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1