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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-24402
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The event was initially evaluated and determined to be non-reportable. The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.
 
Event Description
It was reported that in the picu, the doctor struggled to place the introducer needle into the (b)(6) female patient's jugular, stating it was too long for the procedure. As a result, he attempted to use a blue gelco needle, however, the guide wire would not pass through it. It is unknown if another attempt was tried on the patient with burn wounds. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the reported complaint that the introducer needle was too long for the procedure and the guide wire would not pass through a non- arrow needle used during the second attempt could not be confirmed. The customer returned one guide wire and one introducer needle in an opened kit. Visual examination revealed two kinks near the distal end of the guide wire and the rest appeared typical. No damage was observed with the returned needle. Microscopic examination revealed three kinks at the distal end of the guide wire and two of these had offset coils. Microscopic examination also revealed that both weld were full and spherical and that no damage was observed with the returned needle. A manual tug test was performed on both ends of the wire and both welds were intact. The kinks in the wire were measured at 7 mm, 1. 8 cm and 2. 4 cm from the distal weld. The length of the guide wire measured 352 mm and the outside diameter (od) measured 0. 613 mm both of which do not meet specification for the guide wire packaged in the reported kit (length: 444- 456 mm & od:. 430-. 470 mm). The returned needle with a blue hub is also not from the reported kit. Functional testing was performed with the returned components and the guide wire passed through the needle without resistance other remarks: which does not match what the customer reported. The investigation findings revealed that both returned components are not from the reported kit and do not match the reported complaint of the guide wire not passing through the introducer needle. A device history record review was performed on the guide wire from the reported kit with no relevant findings. Therefore, the cause of this complaint could not be determined. No further action will be taken.
 
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Brand NameCVC SET: 2-LUMEN 4 FR X 13 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5876899
MDR Text Key52164093
Report Number3006425876-2016-00260
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Catalogue NumberCS-24402
Device Lot Number71F16C1922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2016
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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