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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL 200 PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL 200 PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
It was reported that the bd syringe 3ml ll 200 experienced leakage. The following information was provided by the initial reporter: caller reported that when they were filling the cartridge insulin was coming out from the top of the plunger. Did issue cause any injury? - no.
 
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Examination of the product involved may provide clarification as to the cause for the reported failure. 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. Since no samples displaying the reported condition were received a potential root cause could not be defined. Since no samples displaying the reported condition were received corrective actions are not necessary.
 
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Examination of the product involved may provide clarification as to the cause for the reported failure. 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. Since no samples displaying the reported condition were received a potential root cause could not be defined. Since no samples displaying the reported condition were received corrective actions are not necessary.
 
Event Description
It was reported that the bd syringe 3ml ll 200 experienced leakage. The following information was provided by the initial reporter: caller reported that when they were filling the cartridge insulin was coming out from the top of the plunger. Did issue cause any injury? - no.
 
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Brand NameBD SYRINGE 3ML LL 200
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13101620
MDR Text Key285365595
Report Number1213809-2021-00825
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309657
Device Catalogue Number309657
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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