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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 SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383313
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 51 bd saf-t-intima¿ safety system with y adapter 24 ga 0. 75 in had incorrect label content. The following information was provided by the initial reporter: "it was reported that: iv's were coming up expired when item is scanned however the packaging shows that it does not expire until 2024-01-31. Barcode: (b)(4). Per customer response: i currently have 51 in my possession without taking stock from the floor. These 51 all have the same lot and scan expired. How many samples would you need? event description per attached email states:the quality team looked into it. There is an error in the barcode. The barcode showed the expiration of 2020 instead of 2024; it is important to mention that the due date printed on the unit label is the correct as well as the due date printed on shipper and dispenser labels. The quality team will complete a thorough investigation. Questions/inquiries: complaint rationale: based on the information provided, our conclusion is that the device cited meets our criteria of a complaint. Appendix 1: complaint determination tree:(b)(4). Customer is requesting replacement and credit. ".
 
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Brand NameBD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN
Type of DeviceINTRAVASCULAR CATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10457962
MDR Text Key214379374
Report Number9610847-2020-00262
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383313
Device Catalogue Number383313
Device Lot Number0035306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2020
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: 08/26/2020 Patient Sequence Number: 1
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