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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SMARTSITE¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD SMARTSITE¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
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. 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 saline sprayed out through a crack in the unspecified bd smartsite¿ extension set tubing after it had been flushed. The following information was provided by the initial reporter: "chemo microbore tubing was primed with saline and connected to the patient. Nurse attempted to aspirate for blood return, and the syringe was filling with air. Nurse disconnected syringe, and attached a blunt cannula to the end to try and flush, tubing flushed well, removed the blunt cannula to demonstrate the closed system device to a new nurse and saline sprayed out through a crack in the tubing. ".
 
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Brand NameUNSPECIFIED BD SMARTSITE¿ EXTENSION 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13212062
MDR Text Key286653483
Report Number2243072-2021-03076
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,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
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
Date Manufacturer Received01/11/2022
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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