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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Model Number 386806
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/23/2021
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the doctor sustained a needle stick injury in the finger with the bd cathena¿ safety iv catheter with bd multiguard¿ technology after pulling it from the patient. The following information was provided by the initial reporter: dr. In the operating room went to use one of the new iv catheters, he inserted it into a patient but could not get it to thread. He told me he then pulled the iv catheter back and it popped out and stuck him in the finger. I do not believe this was a malfunction of the product, i believe this happened because he did not receive the training. Training was offered to him in person at the end of april which he refused. I then sent him an email march 8th with the education material and again offered training and did not hear back from him. I went to see him today after the incident and offered training from me or the bd reps, he again refused the training.
 
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Brand NameBD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11691225
MDR Text Key262541627
Report Number8041187-2021-00308
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903868063
UDI-Public00382903868063
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201717
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 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number386806
Device Catalogue Number386806
Device Lot NumberUNKNOWN
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 Received06/15/2021
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

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
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