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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS ANESTHESIA CONDUCT KIT Back to Search Results
Model Number IPN040048
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
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
Epidural catheterization kit broke mid procedure. Customer was doing a caudal epidural and in the last part of the procedure the customer noticed a failure in the wall of the catheter specifically. The contrast showed ballooning of the wall. The customer was able to retrieve the catheter with no adverse outcome to the patient that they are aware of. On further inspection of the catheter post-procedure they noticed a longitudinal tear in the wall of the catheter. Due to severity of the issue, the customer is requesting immediate follow-up.
 
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Brand NameEPIDURAL CATHETERIZATION SETS
Type of DeviceANESTHESIA CONDUCT KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key12967573
MDR Text Key281987099
Report Number1036844-2021-00179
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K801912
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 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN040048
Device Catalogue NumberAK-05000
Device Lot Number13F21F0508
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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