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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515052
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
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 #: 1805701, medical device expiration date: 2019-04-30, device manufacture date: 2018-05-22. Medical device lot #: 1806708, medical device expiration date: 2019-11-30, device manufacture date: 2018-06-26. 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.
 
Event Description
It was reported that during use of the bd phaseal optima the p20-o would not re inflate. The following information was provided by the initial reporter: the expected outcome should have the p20-o re inflate once it has been previously deflated. The pir is the protector p20-o is not re inflating when an injectors n35-o is attached. Once the initial 50 ml of air is deflated with 50 ml drug withdraw the expansion chamber is not re-inflating when the n35-o is attached. The expected outcome is to remove the reminder of the drug, demonstrating the expansion chamber needs to re-inflate. Without the expansion chamber it creates great effort and muscle strain as verbalized by the pharmacy technician to withdraw drug. The incident appears to happen consistently with 5fu infuser preparations and with larger dose taxol drugs.
 
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Brand NameBD PHASEAL¿ OPTIMA
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 Key8480664
MDR Text Key148635555
Report Number3003152976-2019-00246
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181221
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 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515052
Device Lot NumberSEE H.10
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 Received03/12/2019
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: 04/03/2019 Patient Sequence Number: 1
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