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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASACULAR ADMINISTRATION SET

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASACULAR ADMINISTRATION SET Back to Search Results
Catalog Number 380510
Device Problem Leak/Splash (1354)
Patient Problem Discomfort (2330)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that the bd q-syte luer access split septum experienced leakage at the luer connection during use. The following information was provided by the initial reporter, translated from (b)(6) to english, verbatim: we have been informed of an incident that has occurred in a (b)(6) hospital center with our pps quick device. Subject of the complaint: "by infusing the patient the huber needle, no abnormality noticed, good blood reflux, no leakage from the valve. At the end of the usual premedication, finding of leakage on the patient's clothing. Immediate stop of the infusion and disconnection of the needle tubing. Finding a leak at the valve. " consequences: delay in the administration of chemotherapy, discomfort for the patient, stress and loss of confidence of trust of the hcw in our equipment. Need to open a new device. Additional financial cost. We have recovered the device in question and have assessed it. We performed a flow test by connecting a bd 10 ml syringe filled with a water / eosin mixture to the q-syte valve. Result: liquid leak at the top of the valve, more specifically through the side hole normally blocked by the valve.
 
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Brand NameBD Q-SYTE LUER ACCESS SPLIT SEPTUM
Type of DeviceINTRAVASACULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9758041
MDR Text Key184626227
Report Number1710034-2020-00118
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number380510
Device Lot Number8120591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2020 Patient Sequence Number: 1
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