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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 REMOVABLE PRN 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 REMOVABLE PRN 24 GA 0.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383312
Device Problems Leak/Splash (1354); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Event Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 24 ga 0. 75 in the damaged tube led to leakage. This occurred twice. There was no report of patient impact. The following information was provided by the initial reporter: on (b)(6) 2022, the head nurse of the respiratory department found that the extension tube of the indwelling needle was damaged and caused blood leakage when the patient was treated with indwelling needle for infusion.
 
Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation. The reported issue of tubing defective / damaged was confirmed upon inspection of the photo. However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation. Examination of the actual product involved may provide clarification as to the cause for the reported failure. A device history record review showed no non-conformances associated with this issue during the production of this batch. A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand NameBD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14598445
MDR Text Key296178386
Report Number9610847-2022-00203
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833123
UDI-Public30382903833123
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383312
Device Catalogue Number383312
Device Lot Number1210971
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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