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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2020
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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.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.(b)(4).
 
Event Description
It was reported that the unspecified bd phaseal¿ optima injector (n35-o) leaked during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "pharmacy tech noticed red on outside of c-100 membrane after using doxo drug.Red was also found on the membrane of the n35 that was attached to the first syringe.".
 
Event Description
It was reported that the unspecified bd phaseal¿ optima injector (n35-o) leaked during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "pharmacy tech noticed red on outside of c-100 membrane after using doxo drug.Red was also found on the membrane of the n35 that was attached to the first syringe.".
 
Manufacturer Narrative
H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.
 
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Brand Name
UNSPECIFIED BD PHASEAL OPTIMA INJECTOR (N35-O)
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11206427
MDR Text Key227983400
Report Number2243072-2021-00147
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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