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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS; PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS; PISTON SYRINGE Back to Search Results
Catalog Number 301027
Device Problems Volume Accuracy Problem (1675); Fitting Problem (2183); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: thirteen loose 5ml syringes (p/n 301027) were received.The samples were visually evaluated.Ten samples that were identified in the verbatim as having "ink dots" were observed to be cylinder dots and acceptable per product specification.One sample was missing its stopper entirely.One sample had illegible and smeared print where the bd logo should be and ink smearing outside of the print area.One sample was identified as having "pollution/dirt" per.It was observed that the foreign matter was not dirt, but ink from the printing process which had smeared outside of the print area.The black dots next to the grad lines are used to monitor the etchings on the print cylinder.Each cylinder has three etchings that become filled with ink and are printed onto each barrel.The dots are used to indicate which etching was used.One etching has no dots, one has one dot, and one has two dots.Batches #0026180 and #0195365 are considered in compliance with our product specification requirements.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.Investigation conclusion: 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.Root cause description: potential root cause for the ink smearing defect is associated with the marking process.Potential root cause for the missing stopper defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Rationale: capa not required at this time.
 
Event Description
It was reported that syringe 5ml ll bns had foreign matter, scale marking issues, and loose plunger.The following information was provided by the initial reporter: 1 syringe with pollution/dirt.1 syringe poorly printed.1 syringe with loose plunger and missing end top.10 syringes with ink dots.
 
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Brand Name
SYRINGE 5ML LL BNS
Type of Device
PISTON 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 Key12163189
MDR Text Key266874455
Report Number1213809-2021-00491
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301027
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/14/2021
Initial Date FDA Received07/13/2021
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
Patient Sequence Number1
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