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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE Back to Search Results
Model Number 309646
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that mold was found in the bd luer-lok¿ syringe sterile, single use before use. This occurred on 10 separate occasions, but the dates are unknown. The following information was provided by the initial reporter: "i was notified this afternoon that we have some syringes in our stock and on the floor that are contaminated/appear to have mold inside of the packaging. Nurses went through items on the floor and found some that appear contaminated to various degrees. More were found in our par bar bin. All the ones that have been found have the same lot # 9242988, exp date of 07/31/2024. " "i know one of our staff members had a near miss with it and had medication drawn into syringe and moved toward i. V. To get ready to administer medication before it was noticed. ".
 
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Brand NameBD LUER-LOK SYRINGE STERILE, SINGLE USE
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 Key9677479
MDR Text Key191535617
Report Number1213809-2020-00067
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309646
Device Catalogue Number309646
Device Lot Number9242988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2019
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: 02/06/2020 Patient Sequence Number: 1
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