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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 EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385101
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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¿ extension set tubing broke. The following information was provided by the initial reporter: "tube broken. ".
 
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Brand NameBD Q-SYTE EXTENSION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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 Key12557639
MDR Text Key274566451
Report Number9610847-2021-00479
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K142527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number385101
Device Catalogue Number385101
Device Lot Number0146032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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