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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT
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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT Back to Search Results
Catalog Number ASK-05500-NRON
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
The medical agent was found leaking from the connection between the catheter and the snaplock adaptor during use on a patient.It occurred to 2 kits in succession.The user replaced the catheter and the snaplock adaptor with a new kit of the same lot by which leak did not occur.
 
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
 
Event Description
The medical agent was found leaking from the connection between the catheter and the snaplock adaptor during use on a patient.It occurred to 2 kits in succession.The user replaced the catheter and the snaplock adaptor with a new kit of the same lot by which leak did not occur.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported the there was a leak between the catheter and the snaplock.The customer returned one 25ml injection syringe, one flat filter nrfit, one snaplock assembly nrfit, and an epidural catheter.The returned components were received connected together (reference attached files (b)(4).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 on the inner coils.No other defects or anomalies were observed.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5; rev.10 using the returned catheter and snaplock assembly with the lab leak tester (ref-002902).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 components were 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 (stopwatch: ref-003150).No leak was observed.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of a leak between the catheter and snaplock could not be confirmed based on the sample received.A device history record review was performed on the catheter and snaplock assembly with no relevant findings.The returned components passed a leak test.Therefore, based on functional testing of the returned sample, no problem was found with the returned sample.No further action is required at this time.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key14468814
MDR Text Key296049417
Report Number3006425876-2022-00521
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 Physician
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2022
Device Catalogue NumberASK-05500-NRON
Device Lot Number71F20K1216
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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