MAUDE Adverse Event Report: CAREFUSION ADAPTER MASK INTIB 22MMX15MM 50/CS; CONNECTOR, AIRWAY (EXTENSION)

Model Number 001820-A

Device Problem Occlusion Within Device (1423)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission-customer advocacy has reached out to customer to provide sample for the 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.

Event Description

Customer reported via email:Əund a o2 adaptor on a patient that was completely occluded.This caused the patient increased breathing difficulties with de-saturation.

• Brand Name: ADAPTER MASK INTIB 22MMX15MM 50/CS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5322874
• MDR Text Key: 34923891
• Report Number: 8030673-2015-00146
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001820-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1