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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN STRAIGHT BC IV CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN STRAIGHT BC IV CATHETER Back to Search Results
Catalog Number 386804
Device Problem Difficult to Remove (1528)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
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 cathena 20gx1. 25in straight bc experienced a safety failure causing a needle stick injury to a nurse. The following information was provided by the customer: consultant completed cannulation with cathena 18g x 32mm under ultrasound guidance. Consultant reported difficulty removing needle shield. It required force by herself & 3 nurses. Needle stick injury occurred once shield had been removed.
 
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Brand NameCATHENA 20GX1.25IN STRAIGHT BC
Type of DeviceIV 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8453995
MDR Text Key139958854
Report Number8041187-2019-00254
Device Sequence Number0
Product Code FOZ
Reporter Country CodeNZ
PMA/PMN Number
N/A
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 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number386804
Device Lot NumberUNKNOWN
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 Received03/07/2019
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: 03/26/2019 Patient Sequence Number: 1
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