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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ORAL SYRINGE
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BECTON DICKINSON UNSPECIFIED BD ORAL SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Code Available (3191)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported unspecified bd oral syringe¿ are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.
 
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.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
 
Event Description
It was reported unspecified bd oral syringe¿ are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.
 
Manufacturer Narrative
Correction: the information was re-evaluated and the complaint does not meet our mdr reporting criteria.The mdr that was submitted previously was sent in error.
 
Event Description
It was reported unspecified bd oral syringe¿ are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.
 
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Brand Name
UNSPECIFIED BD ORAL SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8460880
MDR Text Key141082740
Report Number2243072-2019-00588
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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