MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN914919
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The user was inserting an emergent catheter in the icu.During insertion, just prior to passing the wire, the user noticed a well-em bedded hair within the guidewire and "acted appropriately".No patient harm reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire assembly for evaluation.Visual examination did not reveal any defects or anomalies.No foreign materials were detected in or on the exterior of the guide wire.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The ifu provided with this kit cautions the user, "do not use if package has been previously opened or damaged." the customer report of a foreign material in the guide wire could not be confirmed by investigation of the returned sample.No defects or anomalies were detected with the returned guide wire.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The user was inserting an emergent catheter in the icu.During insertion, just prior to passing the wire, the user noticed a well-em bedded hair within the guidewire and "acted appropriately".No patient harm reported.
Additional Manufacturer Narrative
(b)(4).Additional information received: the customer has provided a photo for evaluation.Visual inspection of the customer photo confirmed a hair was trapped in the guide wire assembly between the straight tubing and the thumb guide.The customer report of a foreign material in the guide wire assembly was confirmed by the returned customer photo.A device history record review was performed with no relevant findings.Based on the customer description and the customer photo, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The user was inserting an emergent catheter in the icu.During insertion, just prior to passing the wire, the user noticed a well-em bedded hair within the guidewire and "acted appropriately".No patient harm reported.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12350864
• Report Number: 9680794-2021-00418
• Device Sequence Number: 17226829
• Product Code: FOZ
• UDI-Device Identifier: 10801902159806
• UDI-Public: 10801902159806
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2021

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: 12/31/2022
• Device Model Number: IPN914919
• Device Catalogue Number: ASK-45703-PMMH
• Device Lot Number: 13F21E0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 11/29/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown