MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; PHASEAL ADMINISTRATION SET

Catalog Number 515008

Device Problem Structural Problem (2506)

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

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 preparing endoxan to be used with a bd phaseal¿ injector luer lock n35j, it had an exposed needle.

Event Description

It was reported that preparing endoxan to be used with a bd phaseal¿ injector luer lock n35j, it had an exposed needle.

Manufacturer Narrative

Investigation summary: a device history review could not be performed as no lot information was provided.Broken safety sleeve the sample was evaluated by jfr lab: visual inspection shows the needle exposed.Visual inspection shows the tip damaged.The needle is bent.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.Conclusion: the breakage of the safety sleeve occurs when the injector is not properly disengaged.In this case, the needle was also damaged due to the wrong handling.If the needle was badly assembled during them manufacturing process, the injector wouldn¿t be functional and couldn¿t be attached to other device.So, this option is discarded.The defect seems to be caused by a misuse by the customer.However, capa 708467 was open prior to the investigation of this complaint to assess the defect.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8400176
• MDR Text Key: 139446010
• Report Number: 3003152976-2019-00192
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00382905150081
• UDI-Public: 382905150081
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/14/2019

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: Other
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other