• 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 EXTENSION SET MICRO BORE 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 EXTENSION SET MICRO BORE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385102
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9350135. The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification. As a sample was unavailable for return, a thorough sample investigation could not be completed and therefor the failure was not confirmed. For further investigations it's recommended that the involved sample be provided for evaluation. Based on the investigation results, an exact cause for this incident could not be identified. Further action has not been determined necessary at this time.
 
Event Description
It was reported when using the bd q-syte¿ extension set micro bore there was leakage and a damaged/deformed product; device is operable. The following information was provided by the initial reporter. The customer stated: "after connecting, there was leaking of fluid and air. The product design interface is not in a straight line with the interface of the blood transfusion device, which is easy to lead to skin indentation of patient ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD Q-SYTE EXTENSION SET 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 Key12185835
MDR Text Key262209129
Report Number9610847-2021-00335
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 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number385102
Device Catalogue Number385102
Device Lot Number9350135
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 Received06/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-