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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¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Model Number 383312
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2022
Event Type  malfunction  
Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation. The reported issue of leakage at catheter junction was not confirmed upon inspection of the photo. 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.
 
Event Description
It was reported that the bd saf-t-intima¿ iv catheter safety system was leaking. The following information was provided by the initial reporter: the head nurse of infection department reported that when the nurse carried out indwelling needle infusion in the ward, the catheter oozed blood after 2 days of indwelling needle.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
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 Key15054221
MDR Text Key302851667
Report Number9610847-2022-00268
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833123
UDI-Public30382903833123
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383312
Device Catalogue Number383312
Device Lot Number1053913
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2021
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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