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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T U100 25G 1IN

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T U100 25G 1IN Back to Search Results
Catalog Number 329622
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. This is the 1st complaint for the reported lot number. A review of the manufacturing records was performed and no non-conformance's were raised in association with this type of event for this lot. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time. Investigation conclusion: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.
 
Event Description
It was reported that 3 syringe 1ml s/t u100 25g 1in experienced a cannula that broke off. The following information was provided by the initial reporter: consumer stated that 3 syringes were not properly attached and the needle came off in the injection site but he was able to remove it, no medical intervention needed. When patient attempted to use the syringe the needle stayed stuck in leg after he goes to pull it off. 2nd time it happened the needle flew off when he was trying to inject his medicine and he lost all his medicine. Before he uses it he makes sure the needle is pressed on really well since they seem like they are not pressed on right or loose.
 
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Brand NameSYRINGE 1ML S/T U100 25G 1IN
Type of DeviceSYRINGE
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 Key12481879
MDR Text Key271721844
Report Number1213809-2021-00640
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number329622
Device Lot Number9072555
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 Received08/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2019
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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