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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem 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.
Additional 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"
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18600873
• Report Number: 9680794-2024-00068
• Device Sequence Number: 2722482
• Product Code: FOZ
• UDI-Device Identifier: 10801902159578
• UDI-Public: 10801902159578
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown