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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515117
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/04/2019
Event Type  Injury  
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 and/or device history review, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that during use of the bd phaseal¿ protector p55 the staff is having pain in their dominant forearm as a result of the push turn push motion of the device. The following email message was received: 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.
 
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Brand NameBD PHASEAL¿ PROTECTOR P55
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 Key8440293
MDR Text Key139465989
Report Number3003152976-2019-00214
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130197
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 Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515117
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
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: 03/21/2019 Patient Sequence Number: 1
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