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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 Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 12/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
The epidural catheter was inserted; the needle removed and a little bit of blood was in the catheter.The catheter was rinsed or flushed immediately but the catheter was blocked.The catheter was removed and replaced.The patient's condition was reported as unknown.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter is blocked.The customer returned one snaplock adapter, one flat filter, one epidural catheter, one 5 ml non-teleflex syringe, and lidstock.The snaplock adapter, catheter, and syringe were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned flat filter revealed the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen within the inner coils of the catheter especially at the distal end of the catheter.A manual flow test was performed using the returned components.A 20 ml lab inventory syringe was connected to the returned flat filter, the returned other remarks: snaplock adapter, and returned catheter.Using hand pressure, the water was injected.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned flat filter with the returned snaplock adapter and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned flat filter or snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 17.8 cm (c05158) from the proximal end of the returned catheter until an occlusion was found.The wire would not thread any further.An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 7 mm before and occlusion was found.The wire would not thread any further.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils and the catheter is completely occluded (b)(4).A corrective action is not required at this time as the condition of the sample received and the information provided indicates that operational context caused or contributed to this event.The reported complaint of catheter being occluded was confirmed based on the sample received.The returned epidural catheter was found to be completely occluded with biological material.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils at approximately 17.8 cm from the proximal end as well as the distal tip.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based on the condition of the sample received and the information provided , operational context caused or contributed to this event.
 
Event Description
The epidural catheter was inserted; the needle removed and a little bit of blood was in the catheter.The catheter was rinsed or flushed immediately but the catheter was blocked.The catheter was removed and replaced.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6257974
MDR Text Key65032770
Report Number3006425876-2017-00008
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberJC-05400-B
Device Lot Number71F16K0702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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