MAUDE Adverse Event Report: CAREFUSION, INC MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG; MASK, OXYGEN, NON-REBREATHING

Catalog Number 001203-A

Device Problem Detachment Of Device Component (1104)

Patient Problems Aspiration/Inhalation (1725); Foreign Body In Patient (2687)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported that the physical sample is unavailable for return and the lot number is unknown.A photograph of the reported issue was provided by the customer.If any additional information becomes available a supplemental submission will be filed.

Event Description

The customer reported, "the disc on the inside of the mask came off and was inhaled by the patient.The patient was able to cough the disc up.The patient coughed it up several days after discharge.There was no harm to the patient".

Manufacturer Narrative

Unfortunately the device used during this reported incident was disposed of by the end-user, and no representative sample was available for further investigation.Without a sample for investigation the reported failure mode could not be confirmed.Carefusion/bd could not review the device history record for the reported device, the lot number was not available.Two years of compliant trends were evaluated and no trend was detected.At this time carefusion/bd is unable to determine a root cause for the failure reported.No corrective actions will be implemented.

• Brand Name: MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5923137
• MDR Text Key: 53782451
• Report Number: 8030673-2016-00220
• Device Sequence Number: 1
• Product Code: KGB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001203-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other