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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 395245
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2023
Event Type  malfunction  
Event Description
It was reported that the bd q-syte stopcock was leaking.The following information was provided by the initial reporter: verbatim: the customer reported about leakage from the stopcock on the iv line.When priming with saline solution, fluid leaked from the stopcock area.
 
Manufacturer Narrative
D.4.Medical device expiration date: unknown, h.4.Device manufacture date: unknown, d4 medical device lot#: 10292202, d.4.The reported lot# [1112202-1 ]was not found for the reported catalog# [395245].H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: a joint atom and bd investigation was performed for the reported issue of leakage.Atom received a sample for investigation and performed a visual inspection as well as a leakage test on the returned sample.No abnormalities or leakage were observed during testing and as a result the cause of the failure could not be traced back to the manufacturing process of the product.Bd was unable to perform a thorough investigation as no lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.H3 other text : see h10.
 
Event Description
It was reported that the bd q-syte stopcock was leaking.The following information was provided by the initial reporter: verbatim: the customer reported about leakage from the stopcock on the iv line.When priming with saline solution, fluid leaked from the stopcock area.
 
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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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17209292
MDR Text Key317939238
Report Number9610847-2023-00159
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 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number395245
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2023
Was Device Evaluated by Manufacturer? Yes
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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