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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHE
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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHE Back to Search Results
Catalog Number ASK-05500-BCW
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2023
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that after insertion, the epidural catheter was not able to be injected through.It was removed and was found to not have a functioning opening at the end.The issue was resolved by inserting a 2nd epidural catheter.There was no harm or injury to the patient.
 
Manufacturer Narrative
(b)(4).The customer reported the catheter was unable to inject.The customer returned one snaplock assembly, an epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A functional flow test was performed.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 8.7ml/min, which is within the specification of 1ml/min minimum.No blockages were found.A device history record review was performed on the epidural catheter with no relevant findings.The reported complaint of the catheter unable to inject 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 and met flow rate specifications.There were no functional issues found with the returned sample.No further action is required at this time.Other remarks: n/a corrected data: n/a.
 
Event Description
It was reported that after insertion, the epidural catheter was not able to be injected through.It was removed and was found to not have a functioning opening at the end.The issue was resolved by inserting a 2nd epidural catheter.There was no harm or injury to the patient.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
CATHETER, CONDUCTION, ANESTHE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16735172
MDR Text Key313247375
Report Number1036844-2023-00032
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05500-BCW
Device Lot Number13F22J0486
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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