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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515003
Device Problems Defective Component (2292); Connection Problem (2900)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462); Chemical Exposure (2570)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device manufacture date: unknown. 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.
 
Event Description
It was reported that a bd phaseal¿ injector luer lock n35 was involved in a needle stick injury. The report is as follows, "rn stuck himself sometime in november does not remember when exactly. It was a couple of weeks after learning the device. He said the product felt faulty from the start. He received two syringes of doxorubicin, tried the first syringe and it wouldn't connect correctly. He disconnected and tried the second syringe which worked fine. He went back to the first syringe and it still did not connect right. He started to check for blood return and realized the product wasn't working right he disconnected and saw the exposed needle. He stuck himself and was exposed to doxorubicin and the patients blood. He did not need treatment and reported it to employee health. ".
 
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Brand NameBD PHASEAL¿ INJECTOR LUER LOCK N35
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8356150
MDR Text Key136720397
Report Number3003152976-2019-00172
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515003
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
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: 02/20/2019 Patient Sequence Number: 1
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