MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK (N35C); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515005

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported with the use of the bd phaseal¿ injector luer lock (n35c) there was an issue with exposure of the needle when the spike set was engaged while changing the drug.

Event Description

It was reported with the use of the bd phaseal¿ injector luer lock (n35c) there was an issue with exposure of the needle when the spike set was engaged while changing the drug.

Manufacturer Narrative

H.6.Investigation summary: the sample was evaluated by (b)(4) report.As no lot information was provided, a device history review could not be performed.The report shows that the cannula is exposed and the grips are out of their place.One decontaminated samples was received: visual inspections reveals some damages close to the grips.This damaged seems to be caused during disengagement.It is confirmed that the sample can be connected to another phaseal device without issues.The injector was disassembled.It was checked that one of the rotation stops is broken.The small broken part was not found during disassembling, therefore this confirms again that the injector was damaged by the customer during disconnection as it is explained in the description ¿blue small parts was fallen¿.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.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.Root cause: the defect seems to be caused by a misuse by the customer.Once the grips are put in their place, the injector is functional, even it is damaged.Capa 708467 has been opened.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK (N35C)
• 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: 8279786
• MDR Text Key: 134313116
• Report Number: 3003152976-2019-00104
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• Combination Product (y/n): N
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other