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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR ADMINISTRATION SET

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BECTON DICKINSON BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR ADMINISTRATION SET Back to Search Results
Catalog Number 515302
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2017
Event Type  Malfunction  
Manufacturer Narrative

Bd corporate headquarters in (b)(4) has been listed in sections. As the actual manufacturing site in (b)(4) is not registered with the fda. Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

 
Event Description

It was reported that the injector/connector of the bd phaseal ¿secondary set c61 with a built-in phaseal¿ connector separated during use. No reported medical intervention or serious injury.

 
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Brand NameBD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR
Type of DeviceADMINISTRATION 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
8015652845
MDR Report Key6904290
MDR Text Key88036648
Report Number2243072-2017-00136
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberN/A
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,Followup
Report Date 12/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number515302
Device LOT Number1004522
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2017
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: 09/29/2017 Patient Sequence Number: 1
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