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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DEHP-FREE GRAVITY 15M FLT 200CM INTRAVASCULAR ADMINSTRATION SET

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BECTON DICKINSON DEHP-FREE GRAVITY 15M FLT 200CM INTRAVASCULAR ADMINSTRATION SET Back to Search Results
Catalog Number 03500104208H
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 09/04/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. The carefusion mfr plant number has not been put in the global trackwise system yet. Therefore, bd corporate headquarters in (b)(4). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that dehp-free gravity 15m flt 200cm was missing label information. The following information was provided by the initial reporter: no label with lot information or expiration date on the blister.
 
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Brand NameDEHP-FREE GRAVITY 15M FLT 200CM
Type of DeviceINTRAVASCULAR ADMINSTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10609476
MDR Text Key217172637
Report Number2243072-2020-01534
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number03500104208H
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 Received09/04/2020
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: 09/30/2020 Patient Sequence Number: 1
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