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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; CATHETER, CONDUCTION, ANESTHE
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; CATHETER, CONDUCTION, ANESTHE Back to Search Results
Catalog Number ASK-05500-BCW
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Unfortunately, we have had a large number of defective filters in the last week.To the point of significantly affective level of patient care.I have so far a tally of 13 noted incidents over a period of less than a week.They are all related to the filter but for different reasons, multiple disconnects, breakages and one that completely fell apart.It is a significant problem for us that needs to be addressed urgently.The epidural catheter was replaced in five of the cases which is reportable.
 
Event Description
Unfortunately, we have had a large number of defective filters in the last week.To the point of significantly affective level of patient care.I have so far a tally of 13 noted incidents over a period of less than a week.They are all related to the filter but for different reasons, multiple disconnects, breakages and one that completely fell apart.It is a significant problem for us that needs to be addressed urgently.The epidural catheter was replaced in five of the cases which is reportable.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the flat filter with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.The customer did provide photos.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 without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the flat filter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
 
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Brand Name
EPIDURAL CATHETERIZATION SETS
Type of Device
CATHETER, CONDUCTION, ANESTHE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11057254
MDR Text Key224134324
Report Number1036844-2020-00337
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/17/2020
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 Date08/31/2022
Device Catalogue NumberASK-05500-BCW
Device Lot Number13F20H0798
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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