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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 20ML LL PRECISE PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 20ML LL PRECISE PISTON SYRINGE Back to Search Results
Catalog Number 300141
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: two photos and one sample were received by our quality team for evaluation. From the photo and sample, it was observed that the product does not belong to the tuas plant manufacturing process. A device history record could not be evaluated as the lot number is unknown. Based on the quality team's investigation, the root cause of this incident cannot be determined. This incident has been added to our database of reported incidents.
 
Event Description
It was reported when using the syringe 20ml ll precise there was foreign matter on device cannula/needle/syringe or any fluid path component. The following information was provided by the initial reporter. The customer stated: there was "excessive lubricant on the plunger in the syringe body. ".
 
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Brand NameSYRINGE 20ML LL PRECISE
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 Key12557773
MDR Text Key274562621
Report Number8041187-2021-00879
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300141
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
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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