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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. CONNECTA Q-SYTE WHT INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 394501
Device Problems Leak/Splash (1354); Retraction Problem (1536)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the connecta q-syte wht connector ring was damaged during use, causing a reflux on the norepinephrine administration route. The patient developed hyptension as a result, and an increase in norepinephrine was prescribed by the doctors. The following information was provided by the initial reporter, translated from (b)(6) to english: twice on 2 different patients and with 2 different caregivers, the connector ring is no longer fixed. This caused a reflux on the norepinephrine administration route. The 2 connectors come from the same batch (defective devices not kept). Classification of the incident : serious deterioration of the health status clinical consequences and current status of the patient or person involved: major hypotension for the patients concerned. Actions taken for the patient regarding the device: incriminated lot set aside pending returns from the supplier. Actions taken in the establishment: declaration of material vigilance. Indeed, doctors prescribed an increase in norepinephrine and asked for closer monitoring.
 
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Brand NameCONNECTA Q-SYTE WHT
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10610942
MDR Text Key209339856
Report Number9610847-2020-00302
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394501
Device Lot Number9310331
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 Received09/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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