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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 INTRAVENOUS CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383336
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence. After analyzing the provided information by customer, this reported defect could be related with an use incorrect from device, besides without sample or photo defective for evaluation, we cannot confirm or associate the defects to manufacturing process. In our process the material is released before to be of packaged and, during this activation have not reported safety mechanism failure and exposed cannula. Instruction sheet (b)(4), show correct way to perform the activation, this instruction no indicate that during the retracting the needle, pvc tubing cannot be enclosed with the clamp slide. P-eura (b)(4) show the procedures used to assemble this product. Root cause description: based on investigation results to date root cause cannot be determined. Rationale: no capa was opened since this issue could not be confirmed as manufacturing related. The initial reporter also notified the fda on 30, march 2018. Medwatch report # mw5076242.
 
Event Description
It was reported by the nurse that the bd saf-t-intima¿ iv catheter safety system device caused a needlestick because of tubing malfunction. When the nurse was retracting the needle, through the enclosed tubing, the needle pierced the tubing and stuck the nurse¿s finger. Reported after use. Medical intervention required.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVENOUS 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 Key7491734
MDR Text Key107560445
Report Number9610847-2018-00134
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903833368
UDI-Public00382903833368
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
Type of Report Initial
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383336
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
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: 05/07/2018 Patient Sequence Number: 1
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