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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 Q-SYTE STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE STOPCOCK Back to Search Results
Catalog Number 395242
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: na.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 q-syte stopcock experienced a loose connection.The following information was provided by the initial reporter: the connection between stopcock and male luer (rock) was loose.In more details, when connecting the male luer (rock) on iv line to the stopcock without q-syte (female luer), the hcp felt like they were slippery.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/1/2021.H.6.Investigation: bd received a sample submitted for evaluation.The reported issue was not confirmed upon testing of the sample.Our quality engineer performed a connection test by utilizing the proper method referenced in the instructions and no connection problems were noted.Since the reported failure was not confirmed a root cause related to our manufacturing process cannot be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that the bd q-syte stopcock experienced a loose connection.The following information was provided by the initial reporter: the connection between stopcock and male luer (rock) was loose.In more details, when connecting the male luer (rock) on iv line to the stopcock without q-syte (female luer), the hcp felt like they were slippery.
 
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Brand Name
BD Q-SYTE 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12789857
MDR Text Key284971235
Report Number9610847-2021-00540
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeJA
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number395242
Device Lot Number0125538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2020
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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