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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
Catalog Number 515005
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Pain (1994)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 that the bd phaseal¿ injector luer lock (n35c) caused "repetitive strain" to the pharmacy worker's forearm as a result of the "push turn push motion" of the device connection, and assessment from occupational health was sought out with recommendations that the worker be removed from the compounding shifts. The following information was provided by the initial reporter: "hi (b)(6), we have had some pharmacy technician staff come forward recently with repetitive strain related pain in their dominant forearm as a result of the push turn push motion of phaseal device connections. They are seeking assessment from occupational health as a result and there may be recommendations to have them removed from the compounding shifts which is concerning. Can you comment if this is occurring at other sites and if you have any strategies in terms of manipulation techniques to help to prevent/mitigate this? much appreciated, (b)(6)".
 
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Brand NameBD PHASEAL¿ INJECTOR LUER LOCK (N35C)
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 Key8433735
MDR Text Key139245542
Report Number3003152976-2019-00211
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515005
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
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: 03/19/2019 Patient Sequence Number: 1
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