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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. Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 385102
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that q-syte ext set, luer-lok 6 in micro bore was damaged and leaked. The following information was provided by the initial reporter: on august 13, 2021, the child was hospitalized with pneumonia and required intravenous fluids. Blood returned was found when the infusion was completed. When the pre-flushing linking tube was used, severe blood reflux was found, and the pre-flushing liquid failed to enter the indwelling needle, so the indwelling needle was closed. Careful observation revealed that the extension tube of the indwelling needle was broken, resulting in blood reflux. The indwelling needle extension tube was replaced and the indwelling needle was fixed again. In this process, the children were afraid of crying violently. Due to equipment problems, the extra bleeding of the children was about 3 ml. The family members were dissatisfied, and their trust in the hospital declined.
 
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Brand NameQ-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
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 Key12550291
MDR Text Key274568984
Report Number9610847-2021-00473
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013621
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 Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385102
Device Lot Number0171924
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 Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2020
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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