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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 Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1712119 medical device expiration date: 2022-11-30 device manufacture date: 2017-12-26; medical device lot #: 1802120 medical device expiration date: 2023-01-31 device manufacture date: 2018-02-20. 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¿ protector p50 there was an issue with the device not fitting together. It was stated ¿despite using the device to fix the adapter 50, the claws of phaseal was too far apart and do not fit on the bottle. The blister was opened and the pharmacist observed the protector wings were enlarged in comparison with some other p50 protectors. ¿ there was no report of injury or further 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 Key7495297
MDR Text Key107724314
Report Number3003152976-2018-00183
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,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Pharmacist
Device Catalogue Number515105
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
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 Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1
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