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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 Problem Connection Problem (2900)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.Device manufacture 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.".
 
Manufacturer Narrative
H.6.Investigation: one picture sample was received for evaluation by our quality engineer.Through visual inspection of the picture sample, the cannula was observed exposed and the grips of the safety sleeve were out of place.Injector needles become exposed if they are not properly disengaged, which also results in safety sleeve breakage.It is important to hold onto the white components of the injector when engaging/disengaging; do not grip the blue safety sleeve.If the grips of the safety sleeve become dislocated, the injector is activated causing needle exposure.To avoid damage to the safety sleeve grips, the injector must be removed by pulled it straight back and it cannot be forcefully engaged.It has been determined that this incident most likely occurred due to improper use.The instructions for use must be carefully followed when using the phaseal devices.Retraining is recommended to prevent this issue's reoccurrence.Dhr: n/a - no lot.
 
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 Name
BD PHASEAL¿ INJECTOR LUER LOCK N35
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8317518
MDR Text Key135496740
Report Number3003152976-2019-00134
Device Sequence Number1
Product Code ONB
UDI-Device Identifier30382905150037
UDI-Public30382905150037
Combination Product (y/n)N
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number515003
Device Lot NumberUNKNOWN
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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