MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR LOCKING N40-O; INTRAVASCULAR ADMINISTRATION SET

Model Number 515056

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that injector locking n40-o had flow issues, disconnection, and leakage.This occurred on 7 occasions.The following information was provided by the initial reporter: material #: 515056.Batch/lot #: unknown.It was reported reading high pressure on 5fu pumps, disconnection, leakage.Verbatim: there have been 7 reported incidents of the optima injector and connector reading high pressure on patient 5fu pumps, causing disconnections are the needless connector and the optima connector (1 time) and the needles connector and the port access needle, causing a stop in infusion and often chemo spills and blood spill on the patient.The needless connector most used in the instances is the max plus and the port access needle is the smith's gripper.Follow up sent to rep regarding incident.Response: per attached: optima injector and connector reading high pressure on patient 5fu pumps, causing disconnections are the needless connector and the optima connector (1 time) and the needles connector and the port access needle, causing a stop in infusion and often chemo spills and blood spill on the patient.They simply stated they get high pressure alarms but they also have been getting them when using halo.This infusion typically runs at 5ml/hour for multiple days.

• Brand Name: INJECTOR LOCKING N40-O
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11867509
• MDR Text Key: 252702171
• Report Number: 3003152976-2021-00280
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: 00382905150562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515056
• Device Catalogue Number: 515056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1