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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 309653
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 and one photo were provided for evaluation by our quality team. A visual inspection was performed and no defects or imperfections were observed. The rubber stopper nor the inner barrel wall show an excess of silicone. In the two photos provided, one shows a syringe out of the packaging blister and the other shows a plunger rod with the rubber stopper out of the syringe barrel. 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 and a probable root cause could not be offered.
 
Event Description
It was reported when using the bd luer-lok¿ tip syringe 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 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 Key12557589
MDR Text Key274558882
Report Number1911916-2021-01046
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 Number309653
Device Catalogue Number309653
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
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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