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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE ADAPTER INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD SYRINGE ADAPTER INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Infusion or Flow Problem (2964)
Patient Problem Underdose (2542)
Event Date 11/03/2020
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 (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. 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. (b)(4).
 
Event Description
It was reported that the unspecified bd¿ syringe adapter connected to the unspecified infusion pump under-infused during use. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: they believe the syringe adapters may at be fault for these under infusions. It would be great to get to the bottom of this issue, it is a critical issue with the type of infusion that we're trying to do with the new syringe adaptor for the 8100 module infusion pump. It is not just 1 pump, or 1 pc that is having this under-infusion issue. It is several. To me it sounds more about the adaptors themselves that are the problem. Many of the under-infusion tests have been run without patient involvement.
 
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Brand NameUNSPECIFIED BD SYRINGE ADAPTER
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10910006
MDR Text Key218575440
Report Number2243072-2020-01951
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
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 Received12/08/2020
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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