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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. SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problem Break (1069)
Patient Problem Local Reaction (2035)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that saf-t-intima w/y adapter yel 24ga x. 75i needle broke. The following information was provided by the initial reporter: this is catheter for subcutaneous or intravenous use. The integrated guidewire is withdrawn and contained within the safety mechanism and then discarded once the device is inserted, leaving a flexible cannula under the skin. In this incident (subcutaneous use), a small part of the guidewire broke off, remained inside the plastic cannula and was not immediately visible/known to be retained on insertion. The patient developed some redness and swelling around the site and when the cannula was removed approx. 12 hours later, the retained guidewire was noted and caused a needlestick injury to the nurse removing the device.
 
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Brand NameSAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11882678
MDR Text Key263522779
Report Number9610847-2021-00232
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383313
Device Lot Number0065730
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 Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2020
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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