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

Device Problem Unraveled Material (1664)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medwatch report # mw5111742.

Event 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.".

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 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
• Type of Device: 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
• MDR Text Key: 301358982
• Report Number: 9680794-2022-00652
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20801902117223
• UDI-Public: 20801902117223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other