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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT NEEDLE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT NEEDLE Back to Search Results
Catalog Number 300263
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
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 bd hypoint needle experienced difficult plunger movement.
 
Event Description
It was reported that the bd hypoint needle experienced difficult plunger movement.
 
Manufacturer Narrative
Investigation summary: there are no returned samples and no returned photos.Since no samples and photos displaying the reported condition were received the root cause could not be determined.Dhr review has been performed and showed no abnormalities.In hypodermic needle process, there is vision system that will reject clogged needle.
 
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Brand Name
BD HYPOINT NEEDLE
Type of Device
NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8348343
MDR Text Key136620142
Report Number8041187-2019-00153
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903002634
UDI-Public00382903002634
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number300263
Device Lot Number7102094
Date Manufacturer Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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