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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX8CM CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX8CM CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number EDC-00818
Device Problems Cut In Material (2454); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Corrected data: lot# corrected to 14f17f0248. Catalog# corrected to edc-00818. Expiration date corrected to 06/30/2019. Device manufacture date corrected to 07/2017. The customer returned one catheter assembly for evaluation. The returned catheter contained signs of use in the form of biological material. Visual examination revealed one hole in the catheter near the distal end. The hole was jagged and contained white coloration, indicative that the needle bevel punctured the catheter. The catheter contained one hole 7mm from the distal tip. The length of the catheter body measured to be 3. 54" which is within specification. A device history record review was performed with no relevant findings. The instructions for use (ifu) provided with this kit cautions the user, "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage. " the reported complaint of a sheared catheter tip was confirmed by complaint investigation. The returned catheter contained one hole near the distal tip. The hole contained jagged edges and white coloration, indicating contact with sharps. The catheter passed all relevant dimensional testing. A device history record review was performed with no relevant findings. Based on the sample received, it was determined that operational context caused or contributed to this event.
 
Event Description
The customer reports: clinician inserted the catheter under ultrasound on patient's left arm and it looked to be in the vessel. Resistance was met when trying to advance the catheter over the needle and when the whole device was pulled out of the patient, the catheter was stuck and could not be easily pulled out. When the device finally did come out, the catheter was sheared at the tip about 1cm proximal. The wire was intact so there was no concern of anything left in the patient. A new device and successfully placed in in the patient's right arm. There was no patient injury or consequence. The patient's condition is reported as "fine. Therapy was reported to be delayed/interrupted.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: clinician inserted the catheter under ultrasound on patient's left arm and it looked to be in the vessel. Resistance was met when trying to advance the catheter over the needle and when the whole device was pulled out of the patient, the catheter was stuck and could not be easily pulled out. When the device finally did come out, the catheter was sheared at the tip about 1cm proximal. The wire was intact so there was no concern of anything left in the patient. A new device and successfully placed in the patient's right arm. There was no patient injury or consequence. The patient's condition is reported as "fine. Therapy was reported to be delayed/interrupted.
 
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Brand NameARROW EXT DWELL CATH DEVICE 20GAX8CM
Type of DeviceCATHETER INTRAVASCULAR THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7247801
MDR Text Key283505246
Report Number9680794-2018-00027
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberEDC-00818
Device Lot Number14F17F0248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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