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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problems Fluid Leak (1250); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2019
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 since the previous complaint two other syringes are defective: one syringe has no resistance, sealing defect and the other has a leak.
 
Event Description
It was reported that since the previous complaint two other syringes are defective: one syringe has no resistance, sealing defect and the other has a leak.
 
Manufacturer Narrative
(b)(4). The customer reported there was no resistance due to a leak with the lor syringe. The customer returned one 10ml plastic lor syringe and lidstock. 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. 4, section 7. 2-positive pressure 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 returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe. The resistance of the returned lor syringe was co mparable to the lab inventory syringe. The luer end of the returned syringe was capped with the plunger completely inserted. An attempt to remove the plunger from the barrel was performed. The plunger seal snapped back when attempting to remove from the barrel. This was also performed with a lab inventory syringe with the same results. This indicates the plunger seal was creating a vacuum with no issues. No corrective action needed at this time since no functional issues were found with the returned lor syringe. The reported complaint of no resistance due to a leak could not be confirmed based on the sample received. The returned lor syringe passed functional testing including a leak test. Also, the returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe. 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.
 
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Brand NameEPIDURAL CATHETERIZATION SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8708832
MDR Text Key148328064
Report Number3006425876-2019-00414
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,foreig
Type of Report Initial,Followup,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19C0265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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