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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL S/C 200 PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL S/C 200 PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was received showing a filled 10ml (p/n 302995) syringe. The photo clearly displayed the syringe scale, which had areas of small and large breaks, along with missing print on every single grad line and the bd logo. It appeared that the markings had been scrapped off. The syringe was non-conforming per product specification. Batch #1082982 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. 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 missing print defect is associated with the assembly process. It is likely the print was scraped off as part of a jam during the barrel feeding process in the assembly machine. 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 10ml ll s/c 200 had scale marking issues. The following information was provided by the initial reporter: it was reported that two syringes. Markings were not complete (ink missing).
 
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Brand NameSYRINGE 10ML LL S/C 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12319205
MDR Text Key266423650
Report Number1213809-2021-00565
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 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302995
Device Lot Number1082982
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 Received07/16/2021
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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