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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number UI-05502
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Information (3190)
Event Date 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. A review of design change history for kit ui-05502, part number nz-05500-001, and kz-05400-002 was performed as a part of this investigation. No design changes have been made to this product in the past two years that would have led to this complaint. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the epidural catheter and needle with no relevant findings. The potential cause of catheter not threading could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. A review of design change history for kit ui-05502, part number nz-05500-001, and kz-05400-002 was performed as a part of this investigation. No design changes have been made to this product in the past two years that would have led to this complaint. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the epidural catheter and needle with no relevant findings. The potential cause of catheter not threading could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.
 
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Brand NameSPINAL ANES/EPIDURAL CATH KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7703865
MDR Text Key114546134
Report Number1036844-2018-00205
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberUI-05502
Device Lot Number23F18C0383
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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