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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT Back to Search Results
Catalog Number OU-05500-NRON
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
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
The catheter was found disconnected from the snaplock adaptor and leak was found. Therefore, the snaplock adaptor was replaced with a new one. No harm to the patient was reported. Additional information: it was found that not only the snaplock adaptor but also the catheter was replaced with a new one.
 
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Brand NameEPIDURAL CATHETERIZATION KIT NRFIT
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 Key12779458
MDR Text Key281396886
Report Number3006425876-2021-01085
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 Foreign,Health Professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberOU-05500-NRON
Device Lot Number71F20H3121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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