MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

Catalog Number 385100

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Heart Failure (2206)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 a patient received an infusion on (b)(6) 2017.At 6:30 am, a nurse found that the bd q-syte¿ luer access split-septum stand-alone device had separated from a connector.Blood had leaked from the connection and the patient suffered heart failure.The patient was sent for emergency treatment.The patient's condition was reported to be stable after treatment was provided.

Manufacturer Narrative

Investigation: lot analysis- device/batch history record review: yes, reason: dhrs are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable.Findings: this incident was an mdr.-dhr review was performed on the following sub assembly lot numbers: 6184939 ¿ this lot number was built on qfa line 4, from july 6, 2016 thru july 8, 2016.216,182.Slit location dimension: the required sample for slit location dimension is 3/blade or 2/blade (6 blades) at blade change, adjustments or start up and every two hours and prior to blade change ¿ the review revealed a total of 282 units were visually inspected.All units were acceptable.Slit visual inspection : the required sample for (quality, centeredness and column tear) is 3/blade or 2/blade (6 blades) at blade change, adjustments or start up and every two hours and prior to blade change.¿ the review revealed a total of 282 units were visually inspected.All units were acceptable.Cell 20 ¿ dukane welder was used on qfa 4.The required visual inspection sample for weld flash and damage is 5/welder (6 welders) at start-up, every two hours and at process adjustment.¿ the review revealed a total of 810 units were visually inspected.All units were acceptable.The required sample for weld strength is 5/welder (6 welders) at start-up; every two hours at process adjustment and after any adjustments are made to station 21 and/or 22 (including any changes to hard stops, grippers, or gripper fingers/alignment) ¿ the review revealed a total of (b)(4) units was torque tested.All units were acceptable.The parameter visual verifications for actuator pressure, velocity, weld collapse distance, hold time (s), amplitude (fixed), amplitude (%),+r & -r time, +r col d (in) & -r col d (in) and ¿r, energy, are performed at start-up, work-order change, after any power outage and after process adjustments.¿ the review revealed the parameters were all within specification, except for +r & -r time, +r col d (in) & -r col d (in) and ¿r, energy.The visuals were not performed.The welder power supply reject signal challenge is performed at power supply replacement and at work-order change.¿ the review revealed the challenge passed.Functional leak test-full assemblies only: the required sample for functional leak is 12 complete parts from good bin every four hours.¿ the review revealed a total of 168 units was torque tested.All units were acceptable.6188849 ¿ this lot number was built on qfa line 3, from july 8, 2016 thru july 10, 2016.180,181.Slit location dimension: the required sample for slit location dimension is 3/blade or 2/blade (6 blades) at blade change, adjustments or start up and every two hours and prior to blade change ¿ the review revealed a total of (b)(4) units were visually inspected.All units were acceptable.Slit visual inspection : the required sample for (quality, centeredness and column tear) is 3/blade or 2/blade (6 blades) at blade change, adjustments or start up and every two hours and prior to blade change.¿ the review revealed a total of (b)(4) units were visually inspected.All units were acceptable.Cell 20 ¿ branson welder was used on qfa 3.The required visual inspection sample for weld flash and damage is 5/welder (4 welders) at start-up, every two hours and at process adjustment.¿ the review revealed a total of (b)(4) units were visually inspected.All units were acceptable.The required sample for weld strength is 5/welder (4 welders) at start-up; every two hours at process adjustment and after any adjustments are made to station 21 and/or 22 (including any changes to hard stops, grippers, or gripper fingers/alignment) ¿ the review revealed a total of 560 units was torque tested.All units were acceptable.The parameter visual verifications for actuator pressure, velocity, weld collapse distance, hold time (s), amplitude (fixed), amplitude (%),+r & -r time, +r col d (in) & -r col d (in) and ¿r, energy, are performed at start-up, work-order change, after any power outage and after process adjustments ¿ the review revealed the parameters were all within specification, except for +r & -r time, +r col d (in) & -r col d (in) and ¿r, energy.The visuals were not performed.The welder power supply reject signal challenge is performed at power supply replacement and at work-order change ¿ the review revealed the challenge passed.Functional leak test-full assemblies only: the required sample for functional leak is 12 complete parts from good bin every four hours.¿ the review revealed a total of 180 units was torque tested.All units were acceptable.Qn / sap database review: yes.Reason: the review of the qn/sap database is required for a s3 - o1 level b investigation per (b)(4).Findings: the qn review revealed (b)(4) for missed inspection that could be associated with this incident.Visual analysis observations and testing: received one used q-syte unit without packaging from the lot number 6209578 accompanying the q-syte was a three valve stopcock with an opened package.Photos provided by customer for review.¿ the photos did not reveal leakage or the q-syte separated from the connector.(see photos provided by customer) visual/microscopic evaluation: ¿ the septum was molded using the 32 cavity mold.¿ slits tears on the septum top disk.¿ there was a sufficient weld line between the top and bottom bodies.Water leak test: the q-syte unit was connected to the water leak test station and tested in the unactuated and actuated positions.¿ leakage was not confirmed in the actuated or unactuated positions during testing.The stopcock was connected to the q-syte unit which was connected to the water leak test station and tested in the actuated position.¿ leakage was not confirmed in the actuated positions during testing.The stopcock was connected to the water leak test station.The q-syte was tested in both the un-actuated and actuated positions on the two valves of the stopcock ¿ no leakage was observed in the actuated or unactuated positions during testing.Functional test (connection): filled the returned 10ml luer lok syringe with a red food coloring/water mix and attached it to the q-syte which was attached to the stopcock and performed flush: ¿ manually pressurized the syringe and expelled fluid through the q-syte.¿ no leakage was observed from any area of the q-syte and the syringe remained attached.Filled a laboratory supplied 10ml slip luer syringe with red food coloring/water mix and attached it to the q-syte which was attached to the stopcock and performed flush: ¿ manually pressurized the syringe and expelled fluid through the q-syte.¿ no leakage was observed from any area of the q-syte and the syringe remained attached.Connection was successful with both the slip luer and the luer lok syringe supplied by the lab; the connections remained secure after each flush and did not pull back or disconnect.The male luer fitting of the q-syte units / p dimension measurement ¿ (the length of the male luer to the end of the luer lock) ¿ (2.1 mm for minimum per iso 594-2) ¿ the measured value was 2.30 mm the male luer fitting of the q-syte units / p dimension measurement ¿ (the length of the male luer to the end of the luer lock): ¿ (2.1 mm for minimum per iso 594-2) ¿ the measured value was 2.31 mm q-syte top body measurement: the q-syte top body was measured per the raw material drawing specifications.¿ major: 306 +/-.002¿.¿ minor: 263 +/-.002.¿ ¿ major thread diameters measurement: 0.3045.¿ ¿ minor thread diameter measurement: 0.2630.¿ septum column tear assessment: ¿ no damage (tear) was observed along the column walls on any of the returned units.Bottom septum evaluation: the returned units were disassembled to evaluate the bottom septum condition.¿ observed no slit tears on the septum bottom disk.¿ no physical/mechanical damage was observed on any of the external areas of the q-syte top or bottom bodies.Photos of the slit centeredness: ¿ the septum slit cut was not off center.Investigation samples(s) meet manufacturing specifications: no, the returned q-syte unit provided for evaluation displayed slit tear on the septum top disk.Was the device used for treatment or diagnosis? treatment comment: (q-syte ifu) general guidelines: the bd q-syte device is intended for use only with the following ¿ intravascular line.¿ iso luer-slip and luer-lock connectors on standard iv administration sets, extension sets and syringes.(q-syte ifu) caution and warning: the bd q-syte device should not be used with needles, blunt cannula, non-iso luers, or iso luers with visible damage.¿ luer slip connections should not be left unattended, due to the potential for disconnection (see q-syte ifu for the details).¿ when connecting or disconnecting from the bd q-syte device, hold the device itself, not the female luer adapter, to avoid over-tightening or accidental removal of the device.¿ when using the bd q-syte device with a luer slip syringe, avoid ¿over twisting¿ as the tip is inserted or removed.¿ when connecting or disconnecting from the bd q-syte device always insert or remove the male luer using a ¿straight-on/straight off approach.Conclusions: the defect of leakage, as stated in the subject of the pir was not confirmed with the returned unit.Confirmed there were slit tears on the septum top disk.Did the evaluation confirm the customer¿s experience with the bd product? no; the customer¿s experience was not confirmed based on the evaluation and testing that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? no; reproduction of the customer¿s experience was not achieved with the testing performed on the returned unit.Root cause relationship of device to the reported incident: indeterminate ¿ 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 ¿ there was no physical/mechanical evidence to confirm or to support manufacturing process.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: LUER 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 Key: 6706148
• MDR Text Key: 79788751
• Report Number: 9610847-2017-00047
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 385100
• Device Lot Number: 6209578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention