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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 Problems Reflux within Device (1522); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
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.Date of event: unknown.The date received by manufacturer has been used for this field.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 that the unspecified bd intravascular administration set experienced air in line, and flow issues.The following information was provided by the initial reporter: the rn used interoperability to program magnesium 2g/50ml bag.This was supposed to run over 2 hours and instead they reported that the pump alarmed air in line and the bag being empty after about 20 mins.We pulled the data from knowledge portal and that is what we see, along with the pump saying that it gave 8.4ml of volume.It happened in our infusion center where they use short sets that are 119cm long (14 ml).The hazardous drug is where the magnesium would have actually been infusing and there was no equashield device.
 
Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the rn used interoperability to program magnesium 2g/50ml bag.This was supposed to run over 2 hours and instead they reported that the pump alarmed air in line and that the bag was empty after about 20 mins 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 and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
Event Description
It was reported that the unspecified bd intravascular administration set experienced air in line, and flow issues.The following information was provided by the initial reporter: the rn used interoperability to program magnesium 2g/50ml bag.This was supposed to run over 2 hours and instead they reported that the pump alarmed air in line and the bag being empty after about 20 mins.We pulled the data from knowledge portal and that is what we see, along with the pump saying that it gave 8.4ml of volume.It happened in our infusion center where they use short sets that are 119cm long (14 ml).The hazardous drug is where the magnesium would have actually been infusing and there was no equashield device.
 
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Brand Name
UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12425086
MDR Text Key271585766
Report Number2243072-2021-02241
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 other,user facility
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
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
Date Manufacturer Received09/22/2021
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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