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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number TU-05500-NRO
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Event Description
It was reported that "the catheter migrated from the patient's body during the medical agent administration in ward.Therefore, the catheter was replaced with a new one.No injury to the patient was reported.According to the user, the patient was delirious and moved a lot, which might have caused the migration of the catheter".Additional information received states that "the catheter did not break.It just migrated/detached from the patient".The catheter was retrieved intact, nothing remained in the patient.The issue was resolved by replacing the catheter.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
Qn#(b)(4).New information received on 17 august 2023 indicates that this was not a reportable event, thus, the initial mdr submitted on 08 august 2023 should be retracted.
 
Event Description
It was reported that "the catheter migrated from the patient's body during the medical agent administration in ward.Therefore, the catheter was replaced with a new one.No injury to the patient was reported.According to the user, the patient was delirious and moved a lot, which might have caused the migration of the catheter".Additional information received states that "the catheter did not break.It just migrated/detached from the patient".The catheter was retrieved intact, nothing remained in the patient.The issue was resolved by replacing the catheter.No patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
Type of Device
ANESTHESIA CONDUCTION KIT
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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key17480236
MDR Text Key320863568
Report Number3006425876-2023-00772
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,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberTU-05500-NRO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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