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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE VET 3ML LL W/NDL 22X3/4 RB

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE VET 3ML LL W/NDL 22X3/4 RB Back to Search Results
Catalog Number 305662
Device Problem Fungus in Device Environment (2316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was received showing four 3ml syringes with needle (p/n 305662) inside their blisterpaks. On each syringe grease like foreign matter could be seen on the flange area and plunger rod thumbrest. The foreign matter also appears to have contacted the bottom web packaging. The observed condition was non-conforming per product specification. Batch #1043991 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 foreign matter defect is associated with the assembly process. It is possible an overapplication of grease during in-process maintenance activities on one of the assembly dials could have contributed to this defect. 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 vet 3ml ll w/ndl 22x3/4 rb had mold. This occurred on 4 occasions. The following information was provided by the initial reporter: it was reported mold.
 
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Brand NameSYRINGE VET 3ML LL W/NDL 22X3/4 RB
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 Key12319089
MDR Text Key266870601
Report Number1213809-2021-00564
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 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 Number305662
Device Lot Number1043991
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
Date Device Manufactured02/12/2021
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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