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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¿ MACROBORE TRI-EXTENSION INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ MACROBORE TRI-EXTENSION INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 385156
Device Problems Insufficient Flow or Under Infusion (2182); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each additional lot number is as follows: medical device lot #: 0036706. Medical device expiration date: 31jan2023. Device manufacture date: 09mar2020. 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 while using bd q-syte¿ macrobore tri-extension the tubing was kinked. This occurred twice. There was no report of patient impact. The following information was provided by the initial reporter: kinked tubing received, that hampering flow rate of infusion.
 
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Brand NameBD Q-SYTE¿ MACROBORE TRI-EXTENSION
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14794364
MDR Text Key298072631
Report Number9610847-2022-00234
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K142527
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 08/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number385156
Device Lot Number0121418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2020
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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