MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515003

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: two unused samples were returned to our quality engineer for investigation.Through inspection, the rotation stops were noted to be broken, resulting in the injectors not being functional.Two retained samples of the same lot were further evaluated, the injector was functional and able to properly attach to the connector without issue, no leakage observed.A device history review was performed for reported lot 1810108, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Injectors go through visual and functional testing throughout the manufacturing process to avoid defects with the product.Based on the available information we are not able to identify a definitive root cause at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.Investigation conclusion: the defect is confirmed: the rotation stops are broken and therefore the injectors are not functional.Two unused samples were received.It is confirmed that they are not functional because rotation stops are broken.Two retained samples were taken for investigation.The injector are functional and it is possible to attach them to the connectors without issues.(no breakage in rotation stops).No leak was confirmed: the syringe can be properly attached to the injector and no leak was found when it is pushed.(the liquid only appears at the end of connector as in this experience was not connected to other device).Inspections and tests: the tests performed during the manufacturing process to avoid faulty parts are listed below: during molding process (according ph-300 current version): visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc).Critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance.The distance between the rotation stops is measured at the beginning of the lot and after a machine stop: go/ no go gauge.Assembly process: (according to ph-301, current version) the following visual inspections are performed by the operator: safety sleeve must be connected and should be turning with the cylinder and piston.The functionality of the grips is verified.Verify the correct welding of the membrane, color and aspect.Cylinder assembly.Piston must be fixed by the safety sleeve.Needle housing should rotate clockwise and tip of the cannula must be observed.Cannula length (with a caliper gauge).Functionality and piston welding test: quality and functionality of the membrane is verified after be welding and punctured by the cannula.Leakage test is performed according to pc-226 to ensure the quality of the membrane.Positive pressure test is performed according to pc-225 to ensure the quality of the sealing.Root cause description: the defect is confirmed: the rotation stops are broken and therefore the injectors are not functional.However, this defect is not confirmed in retained samples.There is no evidence of any failure during the manufacturing process in dhrs.As other similar complaints were received in fy'16, a project was open: # (b)(4).After having visually inspected 69120 samples and having tested 3456 samples, no defective injectors were found during manufacturing process.The defect couldn¿t be connected to an issue during manufacturing process.In fy¿19 a capa was open to assess issues related to injector engagement.This defect is being evaluated under this capa.Rationale: prior to the investigation of this complaint, a capa was open.No more actions are needed.

Event Description

It was reported that the bd phaseal¿ injector luer lock n35 wouldn't connect to the c-45 luer-lock connector during use.The following information was provided by the initial reporter: "i was informed that the nurse [.] had gone to the patient to administer.She was unable to activate and connect the phaseal to the c-45 luer lock connector.Pharmacist tried to connect and activate but was unable to as well as one of the techs when they brought it back to the pharmacy.".

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8449964
• MDR Text Key: 144275144
• Report Number: 3003152976-2019-00219
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 515003
• Device Lot Number: 1810108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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