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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 JC-05400-E
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2019
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
It was reported that just after insertion of the epidural catheter, the doctor noticed it was not possible to infuse the treatment.The catheter seems to be blocked.The filter was changed with the one from the perifix; it still was not working.The catheter was removed.A new kit was used and the same issue, injection blocked, occurred.This time the issue was resolved by replacing the filter with one by braun.
 
Event Description
It was reported that just after insertion of the epidural catheter, the doctor noticed it was not possible to infuse the treatment.The catheter seems to be blocked.The filter was changed with the one from the perifix; it still was not working.The catheter was removed.A new kit was used and the same issue, injection blocked, occurred.This time the issue was resolved by replacing the filter with one by braun.
 
Manufacturer Narrative
(b)(4).A device history record review could not be performed as no lot number was provided by the customer.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.The device history records were not reviewed as no lot number was provided by the customer.Therefore, the potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.
 
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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 Key8455734
MDR Text Key139990849
Report Number3006425876-2019-00246
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 company representative,foreig
Type of Report Initial,Followup
Report Date 03/04/2019
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 Catalogue NumberJC-05400-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/04/2019
Initial Date FDA Received03/27/2019
Supplement Dates Manufacturer Received04/18/2019
Supplement Dates FDA Received04/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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