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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 (NON-DEHP) INTERVASCULAR 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 (NON-DEHP) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383319
Device Problem Leak/Splash (1354)
Patient Problems Pain (1994); Anxiety (2328)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the bd saf-t-intima¿ safety system with y adapter 24 ga 0. 75 in (non-dehp) experienced prn separation from the adapter during use. The product defect resulted in an insufficient dose being administered to the patient and a subsequent bolus dosage. No additional information regarding the patient's condition has been provided. The following information was provided by the initial reporter: details of incident / nature of device defect test y connector, introducor side of y connector, closed with screw bung cap which fell out during use on a syringe driver. Medication not sufficiently delivered to patient. Details of injury (to patient, carer or healthcare professional): medication not delivered/administered at correct dose, too little administered. Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) replaced unit with new unit and new site for administration of subcutaneous end of live medication.
 
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Brand NameBD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN (NON-DEHP)
Type of DeviceINTERVASCULAR 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 Key10420996
MDR Text Key209142980
Report Number9610847-2020-00251
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383319
Device Lot NumberUNKNOWN
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 Received07/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/18/2020 Patient Sequence Number: 1
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