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

Catalog Number 385100

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that liquid leaked from the septum of a bd q-syte¿ luer access split septum standalone device during use.No injury or medical intervention.

Manufacturer Narrative

Investigation: investigation summary: dhr review was performed: (b)(4) per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications, 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.Observations and testing: received one unused q-syte unit in a sealed package from the lot number 6215742.Received one unused nexiva 20 unit.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 un-actuate and actuated positions.Leakage was not confirmed in the actuated or unactuated positions during testing water/air leak test: the q-syte unit was connected to the nexiva straight adapter and then to the lab supplied luer slip connection test fitting and, performed a water/air leak test in the actuated position:, leakage was not confirmed in the actuated position during testing septum column tear assessment: no damage (tear) was observed along the column walls on the returned unit.Bottom septum evaluation: the returned unit was disassembled to evaluate the bottom septum condition.No physical/mechanical damage was observed on any of the external areas of the q-syte top body of the returned unit.Photos of the slit centeredness: the septum slit cut was not off center of the returned q-syte unit.The returned q-syte unit provided for evaluation met and performed to manufacturing specifications in regards to leakage.Investigation conclusion: the defect of leakage, as stated in the subject of the pir was not confirmed with the returned unit.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, per the pir.The defect described in the incident report could not be confirmed or replicated with the returned unit.The customer¿s experience was not confirmed based on the evaluation and testing that was performed on the returned unit.Reproduction of the customer¿s experience was not achieved with the testing performed on the returned unit.Root cause description: an evaluation of the returned q-sytes did not reveal any issues that would contribute to leakage.Rationale: corrections and capa: corrective action project / capa (#): a formal corrective action will not be initiated at this time.A definite root cause that caused the damage described in the pir could not be identified.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.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.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM STANDALONE 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: 6835149
• MDR Text Key: 84626124
• Report Number: 9610847-2017-00067
• 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,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 385100
• Device Lot Number: 6215742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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): Other