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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALARIS PUMP SET; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD ALARIS PUMP SET; 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 03/03/2021
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.Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6), 00000 usa has been used as a placeholder based on the reported phone area code.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 air entered the unspecified bd¿ alaris pump set line during use.The following information was provided by the initial reporter: "air in iv line being passed through the alaris iv pump channel with no alarm.Patient received air infusion of unknown amount for unknown amount of time.".
 
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported by the customer that there was air in the iv line.The customer complaint 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 being 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.
 
Event Description
It was reported that air entered the unspecified bd¿ alaris pump set line during use.The following information was provided by the initial reporter: "air in iv line being passed through the alaris iv pump channel with no alarm.Patient received air infusion of unknown amount for unknown amount of time.".
 
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Brand Name
UNSPECIFIED BD ALARIS PUMP SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12059428
MDR Text Key267155604
Report Number2243072-2021-01741
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 health professional,other,use
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
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 Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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