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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS PISTON SYRINGE Back to Search Results
Catalog Number 300841
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter name and address: (b)(6). Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified. A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found. Based on the quality team's investigation, the root cause of this incident cannot be determined. 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 1ml ls 25ga 5/8in chin graphics had a labeling issue. The following information was provided by the initial reporter, translated from chinese: "after opening the syringe, it was found that there was no scale on the syringe, which could not meet the requirements of drug dosage. ".
 
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Brand NameSYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS
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 Key12334816
MDR Text Key267035139
Report Number8041187-2021-00738
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeCH
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 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300841
Device Lot Number0324292
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 Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2020
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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