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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD Q-SYTE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Dizziness (2194)
Event Date 01/25/2021
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 (b)(4).And the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 3 unspecified bd q-syte¿ devices had air bubbles in the line.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of air bubbles / air in line (3).".
 
Manufacturer Narrative
H6: investigation summary: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text: see h10.
 
Event Description
It was reported that 3 unspecified bd q-syte¿ devices had air bubbles in the line.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of air bubbles/air in line (3).".
 
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Brand Name
UNSPECIFIED BD Q-SYTE
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11346425
MDR Text Key245762056
Report Number2243072-2021-00378
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 03/16/2021
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 NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/18/2021
Supplement Dates Manufacturer Received03/16/2021
Supplement Dates FDA Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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