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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
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
The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex (b)(4) as complaints.).
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the flat filter with no relevant findings.The customer reported the flat filter became detached during use.The customer returned one flat filter nrfit.The returned filter was received with the rotation collar attached to the male lock connector.The returned filter was visually examined with and without magnification.Visual examination of the returned filter revealed the filter appears typical with no observed defects or anomalies.Functional inspection was performed on the returned filter.A lab inventory snaplock assembly nrfit was connected to the male lock c onnector of the returned filter and hand tightening the rotating collar to the snaplock assembly with no issues.An attempt to remove the rotating collar from the male lock connector of the returned filter was performed.Using hand pressure, the rotating collar could not be removed even with much effort.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 flat filter becoming detached during use could not be confirmed based on the sample received.Visual inspection of the returned filter revealed the rotating collar was attached to the male lock connector.Using hand pressure, the returned filter's collar could not be removed from the male lock connector even with much effort.Also, there were no connection issues when connecting the rotating collar using hand pressure to a lab inventory snaplock assembly.A device history record review was performed on the flat filter with no relevant findings.Based on the functional testing, there was no issues found with the returned sample.No further action is required at this time.
 
Event Description
The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex japan as complaints).
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12017248
MDR Text Key260044554
Report Number3006425876-2021-00576
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/11/2021
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 Date11/11/2022
Device Catalogue NumberASK-05500-NRON
Device Lot Number71F20L0376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received06/17/2021
Supplement Dates Manufacturer Received07/26/2021
Supplement Dates FDA Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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