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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK Back to Search Results
Catalog Number 394600
Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
Event Type  malfunction  
Event Description
It was reported that 15 bd connecta¿ stopcocks experienced a loose connection.The following information was provided by the initial reporter: the connection on the side of the venflon simply jumps back, in the best case a leak occurs and in the worst case the device simply disconnects from the patient and the venflon remains open.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jan-2023 h6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no abnormalities or defects on the returned sample.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed by the returned sample analysis.Production records were reviewed, and this batch was in compliance with our product specification requirements.See h10.
 
Event Description
It was reported that 15 bd connecta¿ stopcocks experienced a loose connection.The following information was provided by the initial reporter: the connection on the side of the venflon simply jumps back, in the best case a leak occurs and in the worst case the device simply disconnects from the patient and the venflon remains open.
 
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Brand Name
BD CONNECTA¿ STOPCOCK
Type of Device
STOPCOCK
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16062985
MDR Text Key308477134
Report Number9610847-2022-00506
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394600
Device Lot Number1279946
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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