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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; CATHETER, CONDUCTION, ANESTHETIC
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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Catalog Number OU-05500-NRO
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Event Description
It was reported that solution leaked from the insertion site while in use on a patient.No holes or other damage was found on the catheter.Therefore, it was removed and replaced with a new one.No patient injury as a result of this issue.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The customer reported the catheter was leaking.The customer returned one snaplock assembly nrfit and one epidural catheter.The returned components were received connected.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.Dimensional inspection was not required as a part of this complaint investigation.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).No leak was observed.A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter leaking 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 catheter passed a leak test.There were no functional issues found with the returned sample.No further action is required at this time.
 
Event Description
It was reported that solution leaked from the insertion site while in use on a patient.No holes or other damage was found on the catheter.Therefore, it was removed and replaced with a new one.No patient injury as a result of this issue.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
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
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15868573
MDR Text Key304340191
Report Number3006425876-2022-01019
Device Sequence Number1
Product Code BSO
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/07/2022
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 Catalogue NumberOU-05500-NRO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/07/2022
Initial Date FDA Received11/28/2022
Supplement Dates Manufacturer Received12/21/2022
Supplement Dates FDA Received12/28/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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