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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 Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd phaseal¿ injector luer lock n35 there was an issue with needle through membrane.There was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd phaseal injector luer lock n35 there was an issue with needle through membrane.There was no report of injury or further medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.As a lot number was not provided for this incident, a production history record review could not be completed and retained samples could not be investigated.Since no picture samples or physical samples were available, a thorough sample investigation could not be completed.Needle exposure occurs when the safety sleeve is damaged.Safety sleeve breakage occurs when the injector is not properly engaged/disengaged.It is important to hold onto the white components of the injector when engaging and/or disengaging the device; and not touch the blue safety sleeve.If the grips of the safety sleeve are dislocated, the injector is activated and the needle is exposed.When disengaging the injector, the device must be removed by pulling straight back to avoid grip damage.If the injector has been forced while engaging, the grips may also become damaged.It is important to follow the instructions for use carefully when using the phaseal injector product.As it is explained the breakage occurs when the injector is not properly disengaged.User error.
 
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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 Key7786464
MDR Text Key117436907
Report Number3003152976-2018-00360
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515003
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 07/31/2018
Initial Date FDA Received08/15/2018
Supplement Dates Manufacturer Received07/31/2018
Supplement Dates FDA Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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