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

Catalog Number 515003

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).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.Device manufacture date: unknown.

Event Description

It was reported before use of the bd phaseal¿ injector luer lock n35 leaked into the injector.We are having trouble with the phaseal system and doxorubicin/daunorubicin vials (hospira and pfizer brands).When we draw up the dose using a syringe with an injector attached (p55 protector on the vial) after a couple of minutes the drug is drawn out of the syringe into the injector.My technicians are drawing up the dose and when they disconnect the injector from the protector there is no drug in the injector.It is only 5 mins later when a pharmacist checks the dose that we notice drug has somehow leaked into the injector.

Manufacturer Narrative

Investigation: one photo sample was provided to our quality engineer for investigation which revealed liquid inside the injector piston.As no lot information was available for this incident, a device history record review could not be completed, and additional retained samples could not be investigated.Samples from a different lot were used in attempt to recreate the reported failure.Colored water was successfully withdrawn from a vial using a p55 protector, with no liquid inside the piston.We were only able to replicate this issue when the syringe was pushed and the injector was not activated and properly connected to the device.The defect can be duplicated only making a user mistake.

Event Description

It was reported before use of the bd phaseal¿ injector luer lock n35 leaked into the injector.We are having trouble with the phaseal system and doxorubicin/daunorubicin vials (hospira and pfizer brands).When we draw up the dose using a syringe with an injector attached (p55 protector on the vial) after a couple of minutes the drug is drawn out of the syringe into the injector.My technicians are drawing up the dose and when they disconnect the injector from the protector there is no drug in the injector.It is only 5 mins later when a pharmacist checks the dose that we notice drug has somehow leaked into the injector.

• 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: 8412014
• MDR Text Key: 139446567
• Report Number: 3003152976-2019-00199
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: 00382905150036
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: Health Professional
• Device Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other