• 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 SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER

  • 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 SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation: the reported defect was not confirmed in the image received. (b)(4) units were used to reproduce the reported defect; however, the only way was activating the slide clamp in the pvc tubing right below the wing, as we activate the puller holding the adapter the tube gets tangle. We cannot confirm or associate the reported defect to manufacturing process since, it is not related with our assembly process. Always refer to ifu (b)(4) for product usage recommendations. We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary. No corrective action required at the failure. Process fmea (b)(4) was reviewed and there are proper controls in place to detect product malfunctions. We could not found the exactly root cause of the issue; however, a possible cause could be an incorrect use of the product. No capa was opened since this issue could not be confirmed as manufacturing related.
 
Event Description
It was reported that the safety mechanism on a bd saf-t-intima¿ iv catheter safety system failed to function properly. There was no report of exposure, injury or medical interventions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7565956
MDR Text Key110181765
Report Number9610847-2018-00150
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833130
UDI-Public30382903833130
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number383313
Device Lot Number7143717
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 Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
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: 06/04/2018 Patient Sequence Number: 1
-
-