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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 Consequences Or Impact To Patient (2199)
Event Date 10/02/2017
Event Type  Malfunction  
Manufacturer Narrative

Investigation: a capa has been opened to investigate this issue the investigation concluded: confirmed: bd was able to confirm the customer¿s indicated failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Capa (b)(4) has been opened to investigate this issue. (b)(6). (b)(4).

 
Event Description

It was reported that the connection piece of the bd phaseal ¿secondary set c61 with a built-in phaseal¿ connector detached. There was no report of injury or medical intervention.

 
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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 Key6960138
MDR Text Key90654978
Report Number2243072-2017-00188
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeFI
PMA/PMN NumberK972527
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 Received10/18/2017
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 Received10/02/2017
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: 10/18/2017 Patient Sequence Number: 1
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