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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 5ML CLEAR; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 5ML CLEAR; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305218
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
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 syringe oral 5ml clear had scale marking issues.This was discovered before use.The following information was provided by the initial reporter: material no.: 305218 batch no.: unknown.It was reported that the product received shows a different scale marking than what is shown in the catalogue.
 
Event Description
It was reported that syringe oral 5ml clear had scale marking issues.This was discovered before use.The following information was provided by the initial reporter: material no.: 305218 batch no.: unknown.It was reported that the product received shows a different scale marking than what is shown in the catalogue.
 
Manufacturer Narrative
One unopened 100-count bag of 5ml clear oral syringes from batch 9052610 (p/n 305218) was received and evaluated.No visual defects were observed.A further investigation of the bd online catalog for 305218 was reviewed and was confirmed to have the incorrect scale on the syringe in the photo potential root cause for the incorrect scale in the catalog is likely due to improper update of the catalog.The online catalog will be updated.Expected due date: 2/29/2020.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 5ML CLEAR
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9316302
MDR Text Key191100294
Report Number1213809-2019-01131
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 other,user facility
Type of Report Initial,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305218
Device Lot NumberUNKNOWN
Date Manufacturer Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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