• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Physician opened kit, established vascular access with the introducer needle, threaded wire and when they tried to thread the catheter over the wire, it was noticed that the catheter tip was collapsed and would not accommodate a wire. It was described to the rep. As looking like the tip was, "fused".
 
Event Description
Physician opened kit, established vascular access with the introducer needle, threaded wire and when they tried to thread the catheter over the wire, it was noticed that the catheter tip was collapsed and would not accommodate a wire. It was described to the rep. As looking like the tip was, "fused. ".
 
Manufacturer Narrative
(b)(4). The customer returned one 3-lumen, cvc catheter and lidstock for evaluation. Visual inspection of the catheter revealed that the catheter tip was compressed; however, a spring wire guide was able pass completely through the catheter. Microscopic examination revealed signs of use in the form of an unknown residue was found on the catheter tip and juncture hub. No other defects or anomalies were observed. The returned catheter body from the distal end of the juncture hub to the catheter tip measured 210. 5 mm, which is within the specification limits of 207-227 mm per catheter product drawing. The outer diameter measured was also within specification. A spring wire guide (swg) with diameter of. 032" was passed completely through the catheter starting from the distal tip; no resistance was felt. Also, a lab syringe was used to inject water through all three extension lines. No blockages were observed. A device history record review was performed with no relevant findings. The ifu provided with the kit cautions 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. " the customer complaint that the catheter tip was damaged was confirmed through complaint investigation. The returned catheter showed signs of use in the form of an unknown material on the distal tip and the juncture hub. Starting from the distal tip, a spring wire guide was successfully passed through the catheter, which signifies no other defects or abnormalities within the catheter body. The catheter passed all relevant dimensional testing. A device history record review was performed with no relevant findings to suggest a manufacturing issue. Based on the received sample, unintentional user error caused or contributed to this event. Teleflex will continue to monitor and trend for complaints of this nature.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8045702
MDR Text Key128255019
Report Number1036844-2018-00275
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F17J0276
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-