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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEM 20DP CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET
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GEM 20DP CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0007
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported three gem 20dp ckv 3ss dehp free had air in the line.The following information was provided by the initial reporter: "in the past two weeks or so we have now had 3 incidents where the bd alaris pump infusion set being used.Was found to have an air bubble built up in the ¿chamber.¿".
 
Manufacturer Narrative
H6: investigation summary: one sample (model 2426-0007) was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with saline and placed into an alaris pump.An infusion run was conducted for 1 hour at 125 ml/hr.The infusion run completed without alarming for air in line.The pumping chamber was opened and no air bubbles were present.The customer complaint that the product was found to have an air bubble built up in the ¿chamber" could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported three gem 20dp ckv 3ss dehp free had air in the line.The following information was provided by the initial reporter: "in the past two weeks or so we have now had 3 incidents where the bd alaris pump infusion set being used.Was found to have an air bubble built up in the ¿chamber.¿.
 
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Brand Name
GEM 20DP CKV 3SS DEHP FREE
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12437124
MDR Text Key270321195
Report Number9616066-2021-51982
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403227996
UDI-Public50885403227996
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Date Manufacturer Received09/14/2021
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 Initial
Patient Sequence Number1
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