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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET Back to Search Results
Catalog Number AA-05400-E
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2018
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 the lor syringe was faulty.As the anesthetist went through the patient's skin, the blue rubber moved towards back of syringe and he could not establish if he was in the epidural space or not.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe was faulty.The customer returned one opened kit.The plastic 10ml lor syringe was removed from the kit.The syringe was visually examined with and without magnification.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester (c05176) per the parameters in amrq-000155 rev.04, section 7.2-leakage.Water was aspirated into the syringe to the 8ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.The reported complaint of a faulty lor syringe could not be confirmed based on the sample received.The returned sample passed a functional leak test.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.There were no functional issues found with the returned sample.
 
Event Description
It was reported that the lor syringe was faulty.As the anesthetist went through the patient's skin, the blue rubber moved towards back of syringe and he could not establish if he was in the epidural space or not.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8084278
MDR Text Key127935863
Report Number3006425876-2018-00752
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/10/2019
Device Catalogue NumberAA-05400-E
Device Lot Number71F17G0622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Date Manufacturer Received12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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