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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT Back to Search Results
Catalog Number FR-05501-10
Device Problems Obstruction of Flow (2423); No Flow (2991)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
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
Incident happened on the (b)(6) 2021. The epidural catheter was occluded. So it was difficult to infuse the treatment. We performed few tries to unblock the catheter. The same issue happened for 2 different patients with the same lot#. The consequence was a delay in the treatment of the patients. The devices were discarded.
 
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Brand NameEPIDURAL CATHETERIZATION 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 Key12632996
MDR Text Key278874158
Report Number3006425876-2021-01010
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 Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFR-05501-10
Device Lot Number71F21E1867
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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