MAUDE Adverse Event Report: CAREFUSION/BD MM10 SVN W/TEE 50/CS; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number 002434-A

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion has reached out to customer to provide the complaint device for further investigation.Ups label was provided to the customer.At this time, we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information, we will provide a follow up emdr.(b)(4).

Event Description

The customer reported that when the med neb and the tee adaptor are used together they keep disconnecting during use, when in line with the vent.The respiratory therapists have tried to do the suggested push up and twist during use, and there are still disconnections.This is happening even among patients who don¿t move.¿we have also tried reducing the flow rate of the neb to 6lpm as opposed to up to 8lpm, to reduce back pressure at the connection.We have resorted to placing a thin layer of paper tape around the perimeter of the neb and this sometimes help.The moisture and stickiness of the tape help keep them connected.I don¿t know if the patient got their required dose of medicine¿.The reported item was being used on patient.No patient harm was reported or medical intervention required.The customer confirmed that there is no documentation of respiratory distress, low oxygen saturation or tachycardia due to the failure.¿the disconnection of the med neb from the tee-adaptor could result in the patient not receiving all of their nebulized medication¿.Reported item was being used on patient.No patient harm or medical intervention required.

Manufacturer Narrative

Device evaluation summary: one opened disassembled sample was received for evaluation.During the visual inspection and assembly of this sample it was observed that the tee adaptor part number (b)(4) is not in the bill of materials for this finished good.This tee adapter can be purchased as a standalone component.It was verified that this component can be used with this reported finished good.A push and twist motion must be performed between the tee adapter and the nebulizer for a stable connection.The sample was assembled using this push twist motion and no issues were found with this supplied sample.All components were subjected to a dimension inspection and no issues were found.At this time the reported disconnection cannot be confirmed.The device history record for the reported lot number was evaluated and no issues related with this customers report were found.This product was manufactured, inspected and released in accordance with our internal procedures.Two years of compliant trends were also reviewed and no trend was observed.At this time no corrective actions will be made.

• Brand Name: MM10 SVN W/TEE 50/CS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 6029050
• MDR Text Key: 57399151
• Report Number: 8030673-2016-00245
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 002434-A
• Device Lot Number: 0000912729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention