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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 WITH EXTENSION SET
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK WITH EXTENSION SET Back to Search Results
Catalog Number 394982
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
It was reported that the bd connecta¿ stopcock with extension set valve was stuck and couldn't be turned.The following information was provided by the initial reporter: "after open the package and before using the product, the tap is impossible to turn, it is stucked.".
 
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
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 with extension set valve was stuck and couldn't be turned.The following information was provided by the initial reporter: "after open the package and before using the product, the tap is impossible to turn, it is stucked.".
 
Event Description
It was reported that the bd connecta¿ stopcock with extension set valve was stuck and couldn't be turned.The following information was provided by the initial reporter: "after open the package and before using the product, the tap is impossible to turn, it is stucked.".
 
Manufacturer Narrative
H6: investigation: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
 
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Brand Name
BD CONNECTA¿ STOPCOCK WITH EXTENSION SET
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 Key13470552
MDR Text Key285770372
Report Number9610847-2022-00043
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeSW
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 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394982
Device Lot Number1214543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2021
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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