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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD LUER-LOK TIP SYRINGE PISTON SYRINGE

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BECTON DICKINSON AND COMPANY BD LUER-LOK TIP SYRINGE PISTON SYRINGE Back to Search Results
Model Number 302832
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: it was reported there is excessive lubricant on the plunger in the syringe body. To aid in the investigation, one sample with no packaging blister in a plastic bag and two photos were received for evaluation by our quality team. A visual inspection was performed on the sample, first with a 10x magnifier lens, and then with a 30x microscope. No defects or imperfections were observed. In the two photos provided, one photo shows a rubber stopper assembled to the plunger out of the syringe barrel. The other photo shows a syringe barrel that has some lubricant at the bottom. This is normal and occurs after pressing the rubber stopper at the bottom of the syringe barrel. The lubricant is medical grade and added to the product to make the movement of the plunger rod-rubber stopper smooth. As the lot provided is 'unknown,' a device history record review could not be completed. Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
 
Event Description
It was reported when using the bd luer-lok¿ tip syringe there was 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 NameBD LUER-LOK TIP SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
2153 12th avenue
columbus NE 68601
Manufacturer (Section G)
BECTON DICKINSON AND COMPANY
2153 12th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12557250
MDR Text Key274559524
Report Number1911916-2021-01045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K980987
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 09/14/2021
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 Model Number302832
Device Catalogue Number302832
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
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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