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

Model Number	IPN055565
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The clinician stated guidewire would not easily advance and bend, preventing the guidewire from functioning correctly.No patient harm reported.
Event or Problem Description
The clinician stated guidewire would not easily advance and bend, preventing the guidewire from functioning correctly.No patient harm reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one product lidstock/outer pouch for evaluation.The guide wire was not returned.Visual examination of the lidstock confirmed the reported lot.However, a full visual inspection could not be performed as the guide wire was not returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not withdraw guidewire against needle bevel to minimize the risk of possible severing or damaging of guidewire." the customer report of guide wire damage could not be confirmed without the guide wire to evaluate.A device history record review was performed and no relevant findings were identified.Without the actual 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 20 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11832000
• Report Number: 9680794-2021-00223
• Device Sequence Number: 4367106
• Product Code: FOZ
• UDI-Device Identifier: 10801902156454
• UDI-Public: 10801902156454
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 04/27/2021

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: 04/30/2022
• Device Model Number: IPN055565
• Device Catalogue Number: ASK-45703-LMDTG
• Device Lot Number: 13F21B0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1