• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Back to Search Results
Catalog Number 385100
Device Problems Break (1069); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 01/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Investigation: dhr review was performed on the following sub assembly lot numbers: 7088580 ¿ this lot number was built on qfa line 3, from april 7, 2017 thru april 9, 2017. 7094638 ¿ this lot number was built on qfa line 3, from april 9, 2017 thru april 11, 2017. 7094641 ¿ this lot number was built on qfa line 3, from april 11, 2017 thru april 13, 2017. Review of the dhrs revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans. Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. Set up and in process samples (including but not limited) for air bubbles, slit quality and bond/weld strength were performed throughout the process, all the inspections passed per specifications. No significant discoveries were found. Qn / sap database review: no. Reason: a review of the qn/sap database is not required for a s2 - o1 level a investigation per cpr ¿ 071. The peura (end user risk analysis): yes. Reason: the peura is required for all mdr reportable investigations. Findings: rm5699 rev 5 version d was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Visual analysis observations and testing: received three q-syte units from the lot number 7116693. One used q-syte unit attached to a syringe inside of a tube. Two unused q-syte units in sealed packages visual/microscopic examination: the septums of q-syte units 1 and 3 were molded using the 32 cavity mold. The septum of q-syte unit 2 was molded using the 16 cavity mold. Unit 1 had revealed a small slit tear on the septum top disk. Units 2 and 3 - no physical damage was observed on any of the external areas of the q-syte. Iso air bubble test: the q-syte units were tested in the actuated and un-actuated positions the introduction of air bubbles was observed in the actuated position, not in the un-actuated position on q-syte unit 1. Introduction of air bubbles was not observed in the either the actuated or un-actuated positions during testing on q-sytes units 2 and 3. Water leak test: then q-syte units were leaked tested in the actuated and un-actuated positions. Leakage was confirmed in the actuated position on q-syte unit 1. Leakage was not confirmed in the actuated or un-actuated positions during testing of q-sytes units 2 and 3. Septum column tear assessment: q-syte unit 1 revealed damage (tear) was observed along the column wall. Q-syte units 2 and 3 revealed no damage (tear) was observed along the column wall. Bottom septum evaluation: the returned units were disassembled to evaluate the bottom septum condition. Q-syte unit 1 reveal slit cuts tear on the septum bottom disk. Q-syte units 2 and 3 revealed no damage (tear) on the septum bottom disk. Slit centeredness: the septum slit was not off center on the q-sytes. Investigation samples(s) meet manufacturing specifications: no, the returned q-syte unit 1 provided for evaluation displayed slit tears on top and bottom disk and damage to the column wall. Conclusions: the defect air bubbles/air in line, as stated as the reported code was confirmed with the returned q-syte unit 1. The source of air bubbles/air in line and leakage was the vent hole due to a column tear. Confirmed there were slit tears on the septum top and bottom disks. Did the evaluation confirm the customer¿s experience with the bd product? yes; the customer experienced was confirmed based on the evaluation and testing that was performed on the returned units. Were we able to reproduce the customer's experience with the bd product? yes; reproduction of the customer¿s experience was achieved with the testing performed on the q-syte units. Was the device used for treatment or diagnosis? treatment. Root cause relationship of device to the reported incident: indeterminate. A definite source that caused damage to the column wall; which contributed to the air bubbles, could not be established. The failure modes normally attributed to these types of damage are incorrect usage or excessive actuations. A definite source that contributed to the slit tears could not be established. This type of damage is normally attributed to incorrect usage or excessive actuations. Comment: an instruction pamphlet is provided with q-syte product. This information documents the potential failure modes of this device if not used properly. Corrections and capa corrective action project / capa (#): a formal corrective action will not be initiated at this time. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time. Other action taken: q-syte product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections. These inspections are performed by operators to ensure process changes are identified. If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.
 
Event Description
It was reported that a bd q-syte¿ luer access split-septum stand-alone device, was broken creating ¿alarms¿ during dialysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Type of DeviceQ-SYTE
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 Key7226015
MDR Text Key98850643
Report Number9610847-2018-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number385100
Device Lot Number7116693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
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: 01/29/2018 Patient Sequence Number: 1
-
-