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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML CLEAR; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML CLEAR; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305220
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 syringe oral 3ml clear had scale marking issues.This occurred on 2 occasions.The following information was provided by the initial reporter: the customer complained that the scale can be erased by hand easily.
 
Event Description
It was reported that syringe oral 3ml clear had scale marking issues.This occurred on 2 occasions.The following information was provided by the initial reporter: the customer complained that the scale can be erased by hand easily.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/5/2021.H.6.Investigation: two photos and two loose 3ml oral syringes were received and evaluated.One syringe had a white tip cap attached.It was observed both syringes had large areas of missing print with one syringe having almost no print below the 1.5ml marking and one syringe having no grad lines above the 1ml marking.Based on the verbatim, the reported defect could not be confirmed to originate from the manufacturing site.It was unclear what conditions the syringe was subjected to during the print removal.Potential root cause for the missing print defect could not be defined.Physical unused samples from the same batch are necessary for scale permanency testing.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.
 
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Brand Name
SYRINGE ORAL 3ML CLEAR
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key11586677
MDR Text Key245115019
Report Number1213809-2021-00182
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305220
Device Lot Number8208780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Initial Date Manufacturer Received 03/03/2021
Initial Date FDA Received03/29/2021
Supplement Dates Manufacturer Received04/14/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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