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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 LUER ACCESS SPLIT SEPTUM

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM Back to Search Results
Catalog Number 385100
Device Problems Air Leak (1008); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.  device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while using a bd q-syte¿ luer access split-septum stand-alone device on a dialysis patient, the device broke when connecting it to a toray dialysis route and air was mixed in the route. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation results: device/batch history record review could not be performed as the lot number was not provided. The peura (end user risk analysis) was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. One sample unit was received for evaluation by our quality engineer team. Upon examination, tears were observed on the top of the septum and the septum column. An air bubble test did not result in bubbles in either the actuated or un-actuated position. A water leakage test also did not confirm leakage in the actuated or un-actuated position. Conclusions: the defect air in line, as stated as the reported code was not confirmed with the returned q-syte unit. Although air in line was not confirmed, the presence of the column tear would contribute to the air in the line. Confirmed there were slit tears on the septum top and bottom disks. Root cause is indeterminate. A definite source that caused damage to the column wall; which could allow the air to be in the line, could not be established. The failure modes normally attributed to these types of damage are incorrect usage or excessive actuations. An instruction pamphlet is provided with q-syte product. This information documents the potential failure modes of this device if not used properly. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated monthly. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
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Brand NameBD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Type of DeviceLUER ACCESS SPLIT SEPTUM
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7304214
MDR Text Key101358775
Report Number9610847-2018-00034
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
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: 02/28/2018 Patient Sequence Number: 1
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