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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
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 the bd connecta¿ stopcock disconnected from the iv set.The following information was provided by the initial reporter: "the connection between the stopcock to iv sets is loss and disconnected.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 04-oct-2022 h6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection and testing of the sample.No defects or abnormalities were observed during inspection and no connection issues were experienced during functional testing.Bd cannot determine the cause of the failure since the defect was not confirmed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.
 
Event Description
It was reported that the bd connecta¿ stopcock disconnected from the iv set.The following information was provided by the initial reporter: "the connection between the stopcock to iv sets is loss and disconnected".
 
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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 Key15481731
MDR Text Key306409475
Report Number9610847-2022-00364
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00382903946006
UDI-Public(01)00382903946006
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 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394600
Device Lot Number1244083
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2021
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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