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; 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; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385100
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
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 when using the bd q-syte¿ luer access split-septum there was damaged/deformed product: device is operable.The following information was provided by the initial reporter and translated to english.The customer stated: "there is a defect in the screw when the package is opened.".
 
Event Description
It was reported when using the bd q-syte¿ luer access split-septum there was damaged/deformed product: device is operable.The following information was provided by the initial reporter and translated to english.The customer stated: "there is a defect in the screw when the package is opened.".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one q-syte with opened packaging.During inspection of the unit, no visible damage was observed to the q-syte body or septum.Upon closer inspection, it was observed that the septum had separated from the top body.The reported defect was confirmed.Separation of the top disk from the top body may occur during both manufacturing and in the user environment.During use the defect most commonly results in the septum being pushed into the top body; however, it may also result in separation of the top disk.Septum separation may also occur during manufacturing due to a lack of adhesive or incomplete placement.The unit was microscopically inspected for adhesive residue under the septum top disk.Residue was found to be evenly deposited on the rim, indicating adhesion was present.No other visible damage was observed during the microscopic inspection.As the presence of adhesive was confirmed, bd was unable to determine which scenario was more likely.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h10.
 
Event Description
It was reported when using the bd q-syte¿ luer access split-septum there was damaged/deformed product - device is operable.The following information was provided by the initial reporter and translated to english.The customer stated: "there is a defect in the screw when the package is opened.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12862913
MDR Text Key286012321
Report Number9610847-2021-00565
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30382903851004
UDI-Public30382903851004
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number385100
Device Catalogue Number385100
Device Lot Number1082682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-