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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number TU-05500-J
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
When injecting the medical agent into the inserted catheter, the plunger of the syringe was so hard that the medical agent could not be injected through the catheter.After the catheter was replaced with a new one, the medical agent was re-injected using the same syringe but the same issue was duplicated.A new syringe was used and the therapy was continued without problem.There was no patient injury.
 
Manufacturer Narrative
(b)(4).The customer reported the medication would not inject through the catheter.The customer returned one snaplock adapter, one flat filter, and one epidural catheter.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Biological material can be seen within the inner coils of the catheter especially at the distal end of the catheter.No other defects or anomalies were observed.A manual flow test was performed using the returned catheter, snaplock adapter, and filter.No blockages were found.Other remarks: a device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of medication not injecting into the catheter 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.There were no functional issues found with the returned sample.Teleflex will continue to monitor and trend related events.
 
Event Description
When injecting the medical agent into the inserted catheter, the plunger of the syringe was so hard that the medical agent could not be injected through the catheter.After the catheter was replaced with a new one, the medical agent was re-injected using the same syringe but the same issue was duplicated.A new syringe was used and the therapy was continued without problem.There was no patient injury.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
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
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key6661993
MDR Text Key78233886
Report Number3006425876-2017-00212
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
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 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue NumberTU-05500-J
Device Lot Number71F16F0540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2016
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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