MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW QUAD-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-45854-PUPM1

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported " the j-tip of the guidewire fracture during insertion into angiocath.A small sharp shard of the guidewire developed which pierced a glove." the patient's current condition is "unknown" at the time of this report.Unable to receive additional information for this report.No further complaint details available.

Event Description

It was reported " the j-tip of the guidewire fracture during insertion into angiocath.A small sharp shard of the guidewire developed which pierced a glove." the patient's current condition is "unknown" at the time of this report.Unable to receive additional information for this report.No further complaint details available.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested".A device history record review was performed based on a potential lot from sales history, 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 QUAD-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18600873
• MDR Text Key: 334074696
• Report Number: 9680794-2024-00068
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902159578
• UDI-Public: 10801902159578
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ASK-45854-PUPM1
• Device Lot Number: 66F23G0678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NONE REPORTED; NONE REPORTED