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

Model Number 515005

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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 that during use of the bd phaseal¿ injector luer lock (n35c) when changing medication the needle was exposed.The following information was provided by the initial reporter, translated from (b)(6) to english: the needle was exposed when changing the drug from calboplatin to etoposide.The issue occurred 1 hour after using.

Event Description

It was reported that during use of the bd phaseal¿ injector luer lock (n35c) when changing medication the needle was exposed.The following information was provided by the initial reporter, translated from japanese to english: the needle was exposed when changing the drug from calboplatin to etoposide.The issue occurred 1 hour after using.

Manufacturer Narrative

Correction: the lot number 9095749 reported on the original mdr was reported in error as this lot number does not belong to this device.H.6 investigation summary: one sample was provided and evaluated by our quality team for investigation.Upon visual inspection, the tip of the blue safety sleeve of the injector was observed to be bent.Functional testing was performed, and the injector could connect and disconnected from the connector without issue.Product is visually and functionally tested during manufacturing to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review could not be performed.It is important to hold onto the white components of the injector when engaging/disengaging; do not grip the blue safety sleeve.If the grips of the safety sleeve become dislocated, the injector is activated causing needle exposure.To avoid damage to the safety sleeve grips, the injector must be removed by pulling it straight back and it cannot be forcefully engaged.It was determined this issue likely occurred as a result of improper activation.The instructions for use must be carefully followed when using the phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.H3 other text : see h.10.

• 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: 9323323
• MDR Text Key: 175878193
• Report Number: 2243072-2019-02567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 515005
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other