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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ Y-SITE CONNECTOR C80 ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ Y-SITE CONNECTOR C80 ADMINISTRATION SET Back to Search Results
Catalog Number 515304
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2017
Event Type  Malfunction  
Manufacturer Narrative

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 that during use of the unspecified bd phaseal¿ protector, a nurse attempted to disengage the injector and a piece of the product broke off exposing the needle. There was no report of serious injury or medical intervention.

 
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Brand NameBD PHASEAL¿ Y-SITE CONNECTOR C80
Type of DeviceADMINISTRATION 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 Key6788967
MDR Text Key82790100
Report Number3003152976-2017-00027
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number515304
Device LOT NumberUNKNOWN
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 Received07/24/2017
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: 08/11/2017 Patient Sequence Number: 1
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