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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LS 23GA 1-1/4IN TW

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LS 23GA 1-1/4IN TW Back to Search Results
Catalog Number 301989
Device Problem Sharp Edges (4013)
Patient Problem Laceration(s) (1946)
Event Date 01/08/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the syringe 10ml ls 23ga 1-1/4in tw had a "burr on the flange" that caused a cut to the doctor's finger during use. The customer reported 8 separate occurrences for this event.
 
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Brand NameSYRINGE 10ML LS 23GA 1-1/4IN TW
Type of DeviceSYRINGE
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
8015652845
MDR Report Key8281676
MDR Text Key134340826
Report Number8041187-2019-00113
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301989
Device Lot Number8176291
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2018
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: 01/28/2019 Patient Sequence Number: 1
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