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

Catalog Number 515003

Device Problems Leak/Splash (1354); Activation Failure (3270)

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

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd phaseal¿ injector luer lock n35 there was an issue with leakage.The following information was provided by the initial reporter.Material no.515003 batch no.1810108.It was reported the nurse was unable to activate and connect the phaseal to the luer lock connecter."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." same.We have had leakage between the lure lock connector and needle , from injector lure lock and the syringe, and from the needle when pulling from the sq tissue.

Manufacturer Narrative

H.6.Investigation summary: 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.Injector difficult to engage/disengage.Two 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.Conclusion(s): 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: #1245.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 708467.

Event Description

It was reported that during use of the bd phaseal¿ injector luer lock n35 there was an issue with leakage.The following information was provided by the initial reporter material no.515003 batch no.1810108.It was reported the nurse was unable to activate and connect the phaseal to the luer lock connecter."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." same.We have had leakage between the lure lock connector and needle, from injector lure lock and the syringe, and from the needle when pulling from the sq tissue.

• 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
• MDR Report Key: 8436786
• MDR Text Key: 139443778
• Report Number: 3003152976-2019-00212
• Device Sequence Number: 0
• Product Code: ONB
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• 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
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other