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

Catalog Number 515003

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/07/2018

Event Type  malfunction  

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.

Event Description

It was reported that a bd phaseal¿ injector luer lock n35 had resistance and the plunger of the syringe moved back.

Event Description

It was reported that a bd phaseal¿ injector luer lock n35 had resistance and the plunger of the syringe moved back.

Manufacturer Narrative

Investigation summary: no non-conformance's related to the claimed defect were found during dhr review.2 unopened samples were received for investigation.Flow issues.Visual inspection shows no defects.They were connected to a vial and functional test was performed: expansion chamber worked properly and no flow issues were found.The liquid can move through the set (protector + injector + syringe) without issues.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.As it is explained above, no flow issues were found in the 2 samples of injector received.Based on the description of the complaint, and taking into account the evaluation of the samples, the problems described seem to be an issue related to the protector use.Taking into account the description of the complaint (there was resistance and the plunger of the syringe move back.The balloon of protector did not fill with air) it seems possible that the filter was oversaturated.To avoid this, it is important to carefully follow the instructions explained in the protector ifu (dgp102).The defect was not confirmed on samples received.The defect described by the customer seems to be caused by a misuse of the device.

• 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: 8121311
• MDR Text Key: 129458584
• Report Number: 3003152976-2018-00521
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 515003
• Device Lot Number: 1607005
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other