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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 Problems Leak/Splash (1354); Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954)
Patient Problem Exposure to Body Fluids (1745)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that unspecified bd¿ q-syte was damaged.It had flow issues, air bubbles, leakage, attachment issues, defective septum, and there was blood exposure.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that there were reports of localized infections (30), slow flow rates (281), flow rate occluded (181), leakage (13), clinician exposure to blood (9), q-syte to iso compliant device attachment issues (3), iso compliant device to q-syte septum connection issues (5), q-syte lifts up at rim or becomes unglued (4), damaged/defective devices (10), hemolysis (21), air bubbles / air in line (20).
 
Event Description
It was reported that unspecified bd¿ q-syte was damaged.It had flow issues, air bubbles, leakage, attachment issues, defective septum, and there was blood exposure.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that there were reports of localized infections (30), slow flow rates (281), flow rate occluded (181), leakage (13), clinician exposure to blood (9), q-syte to iso compliant device attachment issues (3), iso compliant device to q-syte septum connection issues (5), q-syte lifts up at rim or becomes unglued (4), damaged/defective devices (10), hemolysis (21), air bubbles / air in line (20).
 
Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.
 
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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 Key11355748
MDR Text Key233288066
Report Number2243072-2021-00466
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,user facility
Type of Report Initial,Followup
Report Date 03/11/2021
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 Received02/19/2021
Supplement Dates Manufacturer Received01/25/2021
Supplement Dates FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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