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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381034
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 09/26/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that bd iag bc pro global pnk 20ga x 1. 16in catheter broke. The following information was provided by the initial reporter: description of the facts: part of the cathlon about 2mm remained in the patient¿s arm when it was removed. The nurse noticed a slight tension, so she pulled slightly on the catheter that broke at the time. Vascular surgeons have been consulted, are of the opinion not to remove the tip of the device if there is no sign of infection or inflammation. Clinical consequences and current status of the patient or person involved: patient encounters gene at arm. There were no particular events concerning his state of health. However, the patient still complains of discomfort where the catheter tip is located.
 
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Brand NameBD IAG BC PRO GLOBAL PNK 20GA X 1.16IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12738333
MDR Text Key280109495
Report Number1710034-2021-00936
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
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,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381034
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
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

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