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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 4 FR X 5 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 4 FR X 5 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number AK-22402
Device Problems Physical Resistance (2578); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample will be returned for evaluation.
 
Event Description
It was reported that the kit was used for central line placement, and the 22ga catheter in kit was used for arterial line placement. It was successful line placement, however, the catheter hub would not luer lock in place. This is what the medical doctor typically uses, and by reports, anesthesia as well. The line had to be rewired using another catheter, and rewire of line was unsuccessful, and arterial access was obtained in the patient. There was no reported patient injury or consequences as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the reported complaint of the 22 ga catheter from the over needle assembly did not lock in place could not be confirmed since no sample was returned for evaluation. However, the reported information states that the 22 ga catheter was used to access an artery and act as an indwelling arterial catheter. The ifu for this product states that the 22 ga catheter over needle assembly can be used for accessing the vein prior to the cvc catheter insertion and does not state that the 22ga catheter can be used as an indwelling catheter. A device history record review did not reveal any manufacturing related issues. The potential cause of the 22ga catheter luer hub connection issues could not be determined based upon the information provided and without a sample; however, use error appears to have contributed to this complaint since the 22 ga catheter was used for an off label function. An in-service was requested for this complaint.
 
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Brand NameCVC KIT: 2-LUMEN 4 FR X 5 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5826704
MDR Text Key50581308
Report Number1036844-2016-00436
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberAK-22402
Device Lot Number23F15M0293
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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