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

Model Number	IPN036482
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5111742.
Event or Problem Description
Medwatch received reports: "while placing a right femoral mml, dr.(b)(6) was removing the guidewire, dr.(b)(6) stated that she felt that the line broke.She removed the mml, and guidewire and it was discovered that the guidewire was frayed and partially came apart, potentially becoming catastrophic to the patient.Dr.(b)(6) decided to discontinue the line insertion.Dr.(b)(6) held pressure over the insertion site to stop the bleeding.Dr.(b)(6) then decided to place a different mml at a different site.The guidewire and packaging for the mml was saved for further investigation.".
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5111742.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.
Event or Problem Description
Medwatch received reports: "while placing a right femoral mml, dr.(b)(6) was removing the guidewire, dr.(b)(6) stated that she felt that the line ?broke?.She removed the mml, and guidewire and it was discovered that the guidewire was frayed and partially came apart, potentially becoming catastrophic to the patient.Dr.(b)(6) decided to discontinue the line insertion.Dr.(b)(6) held pressure over the insertion site to stop the bleeding.Dr.(b)(6) then decided to place a different mml at a different site.The guidewire and packaging for the mml was saved for further investigation.".

• 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 LLC; morrisville NC
• 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: 15563196
• Report Number: 9680794-2022-00652
• Device Sequence Number: 6502257
• Product Code: FOZ
• UDI-Device Identifier: 20801902117223
• UDI-Public: 20801902117223
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN036482
• Device Catalogue Number: CDC-45703-XPB1A
• Device Lot Number: 13F22A0732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown