• 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 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE 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 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 309572
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had mold on it. This was discovered before use. The following information was provided by the initial reporter: material no. 309572 batch no. 9203066. It was reported that mold was noticed on luer lok syringes when dispensing the syringes to a consumer. Pharmacist called to report mold on luer lok syringes (1) full box of individually wrapped syringes. Stated that she was dispensing the syringes to a consumer when she noticed the mold.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9395517
MDR Text Key194839804
Report Number1213809-2019-01194
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,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309572
Device Catalogue Number309572
Device Lot Number9203066
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2019 Patient Sequence Number: 1
-
-