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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; CATHETER, CONDUCTION, ANESTHE
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; CATHETER, CONDUCTION, ANESTHE Back to Search Results
Catalog Number ASK-05500-BCW
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
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
Issue reported: circumstances the epidural was inserted normally but anesthesia was unable to push the test dose down the catheter.In both circumstances it was removed right away and replaced with a new catheter which worked with no difficulties.In both cases it meant the patient had to have the procedure 2 times but was otherwise unharmed.Different physician from other complaint.
 
Event Description
Issue reported: circumstances the epidural was inserted normally but anesthesia was unable to push the test dose down the catheter.In both circumstances it was removed right away and replaced with a new catheter which worked with no difficulties.In both cases it meant the patient had to have the procedure 2 times but was otherwise unharmed.Different physician from other complaint.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was blocked.The customer returned one snaplock assembly and one epidural catheter.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.The customer also provided photos.Both photos show a lidstock.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.8.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester ((b)(4)) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 9.2ml/min (stopwatch: (b)(4)), which is within the specification of 1ml/min minimum.No blockages were found.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter being blocked could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.
 
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Brand Name
EPIDURAL CATHETERIZATION SETS
Type of Device
CATHETER, CONDUCTION, ANESTHE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10748918
MDR Text Key213467905
Report Number1036844-2020-00271
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 foreign,health professional
Type of Report Initial,Followup
Report Date 10/09/2020
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 Date06/30/2022
Device Catalogue NumberASK-05500-BCW
Device Lot Number13F20F0321
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 10/09/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received11/25/2020
Supplement Dates FDA Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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