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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 301027
Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo and ten loose 5ml syringes were received. The samples were visually evaluated. One syringes had partial print incorrectly applied to the barrel at an angle. Most of the print was missing. Two syringes had missing print with some of the numbers missing or mostly missing from the scale markings. Multiple grad lines were broken up, partially printed. The ink appeared to not have been applied correctly during marking operation. Seven syringes had ink dots/smears outside the printing area. Which is rejectable per product specification. Potential root cause for the missing print and ink smears defects is associated with the marking process. These conditions are occurring at/below their expected frequency. Therefore, no corrective action is required at this time. Batch 1097108 is 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.
 
Event Description
It was reported when using the bd plastic non-sterile luer-lok¿ tip syringe there was a damaged, deformed product: device is operable; scale marking issues. The following information was provided by the initial reporter. The customer stated: "there were scale mark issues and the barrels were damaged. " bad impression event occurred 120 times. Damaged/broken event occurred 150 times.
 
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Brand NameBD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE
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 Key12392285
MDR Text Key268991594
Report Number1213809-2021-00604
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301027
Device Lot Number1097108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
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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