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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 385100
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd q-syte¿ luer access split-septum stand-alone device experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the clinical customer gave feedback to the device department.After qsyte was opened, the septum was found to be broken and the product could not be used.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-07 h6: investigation summary our quality engineer inspected the samples and photograph submitted for evaluation.Bd received two q-sytes and one photo.Through visual examination, the samples and photo revealed the top disk of the septum was pushed into the top body confirming the reported defect.No damage to the top body was observed.Microscopic examination of the samples revealed no adhesive residue was present on the side of the pushed in septum.Based on the evidence, it is likely that the units did not receive a sufficient bond at the time of manufacture due to the adhesive not being properly deposited.A device history record review showed no non-conformances associated with this issue during the production of this batch.See h10.
 
Event Description
It was reported that the bd q-syte¿ luer access split-septum stand-alone device experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the clinical customer gave feedback to the device department.After qsyte was opened, the septum was found to be broken and the product could not be used.
 
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Brand Name
BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key11103129
MDR Text Key227047657
Report Number9610847-2020-00442
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903851003
UDI-Public00382903851003
Combination Product (y/n)N
PMA/PMN Number
K013621
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 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot Number0006388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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