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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALARIS INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD ALARIS INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
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. Device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. The customer complaint of tubing disconnected and leaking 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.
 
Event Description
It was reported that the unspecified bd alaris" infusion set tubing disconnected from the bag during the magrolimab infusion. The following information was provided by the initial reporter: "rn assisted patient to restroom. Upon returning from restroom, rn found magro tubing disconnected from magro bag. Wet floor was noted inside restroom. Magrolimab infused through alaris pump (b)(4) with a volume of 118. 8 ml remaining, per alaris pump. Dr. Informed. Inv research team notified by pharmacy. The remaining volume will not be replaced, per inpatient pharmacy services. Chemo spill cleaned up per (b)(6) policy.
 
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Brand NameUNSPECIFIED BD ALARIS INFUSION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12554928
MDR Text Key274252707
Report Number2243072-2021-02416
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer 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

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