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

Catalog Number CDC-45703-XP1A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the guidewire kinked/frayed.The physician reported the guidewire would not thread and when removed, it was discovered the end was frayed.The kit was discarded and another kit had the same issue.No patient harm or injury reported.The patient's condition is reported as fine.

Event Description

It was reported the guidewire kinked/frayed.The physician reported the guidewire would not thread and when removed, it was discovered the end was frayed.The kit was discarded and another kit had the same issue.No patient harm or injury reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11448718
• MDR Text Key: 238927477
• Report Number: 9680794-2021-00113
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 13F21A0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1