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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Model Number IPN920760
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2024
Event Type  malfunction  
Event Description
It was reported that "leak at level of the catheter tubing when testing the device once inserted".Additional information received states "there was no consequence for the patient".No medical intervention was necessary.
 
Manufacturer Narrative
(b)(4) other remarks: n/a corrected data: n/a.
 
Manufacturer Narrative
(b)(4).The customer reported the catheter was leaking.The customer returned one snaplock assembly, an epidural catheter, and lidstock.The returned snaplock and catheter 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 that the catheter appears used as biological material can be seen between the inner coils.Microscopic examination of the catheter revealed the catheter is damaged at approximately 10.7cm from the distal end.The extrusion appears to have a cut/hole.No other damage was observed.Functional inspection was performed on the returned sample.A functional leak test was performed using the returned catheter and returned snaplock assembly with the lab leak tester.The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the cat heter has a hole at 10.7cm from the distal end, which was revealed during the visual inspection.No other leaks were detected.A device history record review was performed on the epidural catheter with no relevant findings.The reported complaint of the catheter leaking was confirmed based on evaluation of the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 10.7cm from the distal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.
 
Event Description
It was reported that "leak at level of the catheter tubing when testing the device once inserted".Additional information received states "there was no consequence for the patient".No medical intervention was necessary.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18810972
MDR Text Key336992260
Report Number3006425876-2024-00187
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN920760
Device Catalogue NumberJC-05400-B
Device Lot Number71F23G0069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/05/2024
Initial Date FDA Received02/29/2024
Supplement Dates Manufacturer Received03/04/2024
Supplement Dates FDA Received03/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2023
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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