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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100J ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100J ADMINISTRATION SET Back to Search Results
Catalog Number 515310
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2018
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 a bd phaseal¿ infusion adapter c100j did not flow after the nurse tried to insert a spike needle to the c100j. There was no report of exposure, serious injury, or medical intervention.

 
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Brand NameBD PHASEAL¿ INFUSION ADAPTER C100J
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 Key8065590
MDR Text Key128050335
Report Number3003152976-2018-00490
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK110023
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 12/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number515310
Device LOT Number1712103
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2017
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: 11/13/2018 Patient Sequence Number: 1
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