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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515105
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation results: summary: two pictures and one sample were received by our quality team for investigation. Upon visual inspection of the pictures received, it was verified that the protector does not fit the vial, however, the pictures show that there is plastic covering the vial. This plastic may prevent the proper connection of the protector. Upon evaluation of the sample received, the protector fit properly to the vial and no leak was found. A device history record review found no non-conformances associated with this issue during production of this batch. The p50 protector is intended to be used with 20 mm diameter vials as explained in the instructions for use. The m12 assembly fixture makes the connection easier. However, the vial must be used without accessories which may prevent the proper connection of the protector. To guarantee the function of phaseal devices, it is recommended to carefully follow instructions explained in the instructions for use. Conclusion/root cause: the pictures confirm that the protector does not fit the vial: however, the pictures shows a plastic covering the vial. The plastic may avoid the properly connection of the protector. No defects were found in the sample received (it fitted properly the vials and no leak was found). No qn's or other events that may caused the claimed defect were found during dhr review. P50 protector is intended to be used with 20 mm diameter vials as it is explained in the ifu ((b)(4)). Instructions in the ifu must be carefully followed to ensure the properly work of phaseal items. M12 assembly fixture makes the connection easier. However, the vial must be without accessories which may avoid the properly connection of the protector.
 
Event Description
It was reported while using a bd phaseal¿ protector p50, it was "not correctly fixed on the vial" which could result in leakage of medication. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD PHASEAL¿ PROTECTOR P50
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
8015652845
MDR Report Key7512329
MDR Text Key108378771
Report Number3003152976-2018-00176
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515105
Device Lot Number1802120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2018
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: 05/14/2018 Patient Sequence Number: 1
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