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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05502
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 05/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
This complaint was reported via medwatch from fda #(b)(4).The complaint states: epidural catheter attempted to advance with placement, catheter did not thread and was withdrawn.The tip marker did not come back when catheter was removed.Less than 2mm of the tip of the epidural catheter was retained.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.The customer did provide a photo that shows a damaged catheter (reference files pic2-tc# (b)(4).A review of design change history for kit ak-05502, part number nz-05500-001, and kz-05400-002 was performed as a part of this inves tigation.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 customer did provide a photo that shows a damaged catheter.However, without the actual sample, the potential cause of catheter not threading could not be determined based upon the information provided.
 
Event Description
This complaint was reported via medwatch from fda #(b)(4).The complaint states: epidural catheter attempted to advance with placement, catheter did not thread and was withdrawn.The tip marker did not come back when catheter was removed.Less than 2mm of the tip of the epidural catheter was retained.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8707992
MDR Text Key148305620
Report Number1036844-2019-00690
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Catalogue NumberAK-05502
Device Lot Number23F19A0550
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received07/18/2019
Supplement Dates FDA Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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