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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT Back to Search Results
Catalog Number ASK-05500-NRON
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
A crack was found on the female connector of the flat filter during use on a patient.Therefore, the catheter was removed and replaced with a new kit.
 
Event Description
A crack was found on the female connector of the flat filter during use on a patient.Therefore, the catheter was removed and replaced with a new kit.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was opened for lot # 71p20k0006, based on a design change that was not released before updated material was utilized.Not relevant to this complaint.The customer reported a crack was found on the filter during use.The customer returned one flat filter nrfit.The returned filter was visually examined with and without magnification.Visual inspection of the returned filter revealed the filter has a crack on the female connector end.The filter is also used as the filter membrane has a yellowish tint.No other defects or anomalies were observed.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of a crack was found on the filter during use was confirmed based on the sample received.Visual examination of the returned filter revealed a crack at the female connector end.A device history record review was performed on the flat filter with no findings relevant to this complaint issue.It is unknown how the filter was handled prior to and during use or pressure used.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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 Key12779100
MDR Text Key281394282
Report Number3006425876-2021-01035
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 10/26/2021
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 Expiration Date11/29/2022
Device Catalogue NumberASK-05500-NRON
Device Lot Number71F20L1272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2021
Initial Date FDA Received11/09/2021
Supplement Dates Manufacturer Received12/10/2021
Supplement Dates FDA Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2020
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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