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

Catalog Number CDC-45703-1A

Device Problems Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the doctor had an unsuccessful attempt at placing the guidewire.The patient was not harmed.A midline was placed and other peripherals ivs.The doctor charted that the guide wire began to uncoil in the catheter during attempted guidewire removal from the catheter.The guidewire and catheter were removed as a unit.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

The customer reports that the doctor had an unsuccessful attempt at placing the guidewire.The patient was not harmed.A midline was placed and other peripherals ivs.The doctor charted that the guide wire began to uncoil in the catheter during attempted guidewire removal from the catheter.The guidewire and catheter were removed as a unit.

• Brand Name: ARROW 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8888230
• MDR Text Key: 154138513
• Report Number: 9680794-2019-00314
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: CDC-45703-1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1