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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
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UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.Initial reporter facility name: (b)(6).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 that unspecified bd intravascular administration set experienced an air in line alarm during use, and flow issues.The following information was provided by the initial reporter: pump channel was ringing air in line for an infusion of iv insulin.I trouble shooted air in line alarm, and despite no visible air in line pump channel continued to ring off air in line, therefore writer disconnected the line from patient and proceeded to remove iv line from pump and re-primed a new iv line.I then went and placed the new iv line into the same pump channel and closed the channel.Before attaching line to patient i opened the roller clamp and witnessed the iv drip chamber dripping by itself and draining from the iv line even though the pump channel was off and channel door was closed.At this time the iv line was not attached to the patient.So then i promptly removed the iv line from the channel and removed said channel from alaris pump brain and a new channel was used in its place.
 
Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of dripping from iv drip chamber could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample received, an investigation could not be performed and a root cause could not be determined.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 that unspecified bd intravascular administration set experienced an air in line alarm during use, and flow issues.The following information was provided by the initial reporter: pump channel was ringing air in line for an infusion of iv insulin.I trouble shooted air in line alarm, and despite no visible air in line pump channel continued to ring off air in line, therefore writer disconnected the line from patient and proceeded to remove iv line from pump and re-primed a new iv line.I then went and placed the new iv line into the same pump channel and closed the channel.Before attaching line to patient i opened the roller clamp and witnessed the iv drip chamber dripping by itself and draining from the iv line even though the pump channel was off and channel door was closed.At this time the iv line was not attached to the patient.So then i promptly removed the iv line from the channel and removed said channel from alaris pump brain and a new channel was used in its place.
 
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Brand Name
UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12380362
MDR Text Key268727767
Report Number2243072-2021-02183
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/30/2021
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 Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/30/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received08/30/2021
Supplement Dates FDA Received09/02/2021
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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