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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 24 G X 0.75 IN. INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  malfunction  
Manufacturer Narrative
Results: a sample was not returned for evaluation. A photo was evaluated and showed an activated safety device and the cannula within of the pvc extension tubing. This reported defect was not confirmed since that the safety device was found activated. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6092603. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that after successful iv insertion with a bd saf-t-intima iv catheter safety system 24 g x 0. 75 in. , the needle separated from the guidewire when the needle was withdrawn. There was no report of injury or medical intervention.
 
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Brand NameBD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 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
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 Key6672524
MDR Text Key249132710
Report Number9610847-2017-00041
Device Sequence Number1
Product Code FOZ
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Catalogue Number383313
Device Lot Number6092603
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2016
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: 06/28/2017 Patient Sequence Number: 1
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