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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LS PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LS PISTON SYRINGE Back to Search Results
Catalog Number 302106
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined. A device history record could not be evaluated as the lot number is unknown. Examination of the product involved may provide clarification as to the cause for the reported failure. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported syringe 3ml ls had discolored packaging. The following information was provided by the initial reporter, translated from (b)(6): "the mount below is dark blue or dark blue near red. Each one is individually packaged, but is there no doubt that it is interpreted as sterilized?".
 
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Brand NameSYRINGE 3ML LS
Type of DevicePISTON SYRINGE
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 Key12475403
MDR Text Key271506714
Report Number8041187-2021-00841
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
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
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302106
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 Received08/18/2021
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

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