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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED CONNECTOR INTRAVENOUS MAXZERO NEEDLELESS INTRAVENOUS ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED CONNECTOR INTRAVENOUS MAXZERO NEEDLELESS INTRAVENOUS ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Exposure to Body Fluids (1745)
Event Date 10/25/2018
Event Type  Injury  
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. Other occupation: strategic sourcing buyer, supply chain. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. A device history review could not be completed as no batch number was provided. Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
 
Event Description
It was reported that the technician was flushing the unspecified connector intravenous maxzero needleless iv line through the luer-lock and "blood came from the lure lock out and sprayed her in the face and mouth" upon removal of the syringe. However, there was no medical intervention reported.
 
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Brand NameUNSPECIFIED CONNECTOR INTRAVENOUS MAXZERO NEEDLELESS
Type of DeviceINTRAVENOUS 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
8015652845
MDR Report Key8201300
MDR Text Key131582305
Report Number2243072-2018-01875
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
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 Received12/10/2018
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 Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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