• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1 RB PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1 RB PISTON SYRINGE Back to Search Results
Model Number 309644
Device Problem Fungus in Device Environment (2316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: 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. 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 that a syringe 10ml ll w/ndl 20x1 rb was found to have mold presence before use. The following was reported by the initial reporter: "a registered nurse (rn) contacted fresenius customer service to report that one syringe in the middle of the box is growing mold. There was no patient involvement, no patient harm, or adverse event reported at intake. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 10ML LL W/NDL 20X1 RB
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 Key12054555
MDR Text Key266701315
Report Number1213809-2021-00444
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 health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309644
Device Catalogue Number309644
Device Lot Number0345477
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 Received05/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-