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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10 INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10 INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383734
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device brand name: bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1. 00in 0. 9mm x 25mm. 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 the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap) 22ga x 1. 00in 0. 9mm x 25mm experienced leakage at adapter and tubing. The following information was provided by the initial reporter: leakage was found at the end of the extension tube before injection.
 
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Brand NameSEE H10
Type of DeviceINTERVASCULAR 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
8015296192
MDR Report Key11061683
MDR Text Key223458630
Report Number8041187-2020-00863
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PENDING
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 02/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383734
Device Lot Number0197307
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 Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
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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