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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL W/O DN PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL W/O DN PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter zip:(b)(6). Investigation summary: no sample or photo was available for review. Based on the description, it is possible the observed substance is silicone residue. It would be helpful to evaluate samples to confirm the reported defect. Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products. It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function. The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel. Silicone has been in use in this application for over 20 years. No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant. Silicone is applied as a spray of particles to the inside of the barrel. It is unclear what type of storage and handling conditions the product was subjected to after leaving the manufacturing plant. It is possible certain conditions outside manufacturing environment contributed to the attachment of silicone to the barrel walls as reported by customer. Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported 10 syringe 1ml ll w/o dn had foreign matter. The following information was provided by the initial reporter: "they have noticed a cloudy appearance on the surface of the barrel inside the syringe, in the space encapsulated by the rubber plunger. ".
 
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Brand NameSYRINGE 1ML LL W/O DN
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12616551
MDR Text Key276238299
Report Number1213809-2021-00708
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K941562
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 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309628
Device Catalogue Number309628
Device Lot Number0113765
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 Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2020
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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