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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 (N35C); INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK (N35C); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 515005
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
 
Manufacturer Narrative
Medical 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.Device manufacture date: unknown.
 
Manufacturer Narrative
Medical 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.Device manufacture date: unknown.
 
Event Description
It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
 
Event Description
It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
 
Manufacturer Narrative
H6: investigation summary: one injector and photos was provided to our quality team for investigation.Through visual inspection, the injector membrane was noted to have been penetrated multiple times, and the injector grips are moved from their original place.Product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.Fragmentation test is carried out during production, samples are connected to a matting component and penetrated 10 times each for being tested for coring.If any issue would have been occurred it would have been detected during testing.Moreover, a leakage test is also performed.Samples are connected to a matting component and penetrated 10 times each for being tested for leakage.If any issue would have been occurred it would have been detected during testing.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the investigation and sample evaluation, it was determined this incident is related to improper engagement/disengagement of the device.H3 other text : see h10.
 
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Brand Name
BD PHASEAL¿ INJECTOR LUER LOCK (N35C)
Type of Device
INTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12865432
MDR Text Key285474547
Report Number3003152976-2021-00786
Device Sequence Number1
Product Code ONB
UDI-Device Identifier50382905150055
UDI-Public50382905150055
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number515005
Device Catalogue Number515005
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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