Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 385100
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2022
Event Type  malfunction  
Event Description
It was reported that 24 bd q-syte¿ luer access split-septum stand-alone devices had slow flow issues during use.The following information was provided by the initial reporter, translated from chinese: "use q-syte to connect the hemodialyzer, the instrument alarms, indicating that the flow rate is not enough, remove the connector, the hemodialyzer has no alarm problem".
 
Manufacturer Narrative
Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
 
Event Description
It was reported that 24 bd q-syte¿ luer access split-septum stand-alone devices had slow flow issues during use.The following information was provided by the initial reporter, translated from chinese: "use q-syte to connect the hemodialyzer, the instrument alarms, indicating that the flow rate is not enough, remove the connector, the hemodialyzer has no alarm problem".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Type of Device
INTRAVASCULAR 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 Key15491243
MDR Text Key306363719
Report Number9610847-2022-00369
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903851003
UDI-Public(01)00382903851003
Combination Product (y/n)N
Reporter Country CodeCH
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 10/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot Number1271367
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-