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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 Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/17/2018
Event Type  Injury  
Manufacturer Narrative
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 when using a bd phaseal¿ injector luer lock n35 the injector became disconnected, the needle became exposed and stuck the nurses finger.The nurse was sent to the emergency room to exam and test.No further information was reported regarding the medical intervention.
 
Manufacturer Narrative
Additional information: there were two potential lot numbers reported.Medical device lot #: 1804101, medical device expiration date: 9/30/2020, device manufacture date: 4/5/2018, medical device lot #: 1612103, medical device expiration date: 6/30/2019 and device manufacture date: 12/13/2016.Investigation summary: 1 picture was received.The needle is exposed and the grips of the safety sleeve are broken and out of their place.A device history record review did not reveal any anomalies during the production of either lot number that could have contributed to this incident.The exposed needle is a result of the broken safety sleeve.Inspections and tests: the tests performed during the manufacturing process to avoid faulty parts are listed below: during molding process (according ph-300 current version): visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc).Critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance.Assembly process: (according to ph-301 current version) the following visual inspections are performed by the operator: safety sleeve must be connected and should be turning with the cylinder and piston.The functionality of the grips is verified.Verify the correct welding of the membrane, color and aspect.Cylinder assembly.Piston must be fixed by the safety sleeve.Needle housing should rotate clockwise and tip of the cannula must be observed.Cannula length (with a caliper gauge).Functionality and piston welding test: quality and functionality of the membrane is verified after be welding and punctured by the cannula.The exposure of the needle is caused due to the breakage of the safety sleeve.This breakage occurs when the injector is not properly disengage.It is important to hold onto the white part of the injector before engaging/disengaging.Do no touch the blue part: if grips of the safety sleeve are removed from their place, the injector is activated causing needle exposure.The injector must be removed pulling it back: if it is removed without doing this the grips are removed from their place and needle exposure happens.If the injector has been forced while engaging, the grips can also get damaged.
 
Event Description
It was reported that when using a bd phaseal¿ injector luer lock n35 the injector became disconnected, the needle became exposed and stuck the nurses finger.The nurse was sent to the emergency room to exam and test.No further information was reported regarding the medical intervention.
 
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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 Key8048224
MDR Text Key126499381
Report Number3003152976-2018-00479
Device Sequence Number0
Product Code ONB
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
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 Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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