MAUDE Adverse Event Report: CAREFUSION MASK NON-REBREATHER ADULT W/SAFETY VENT; MASK, OXYGEN, NON-REBREATHING

Model Number 001211-A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2015

Event Type  Injury  

Event Description

Fall apart reservoir bag looks like the adhesive did not hold.Issue detected when patient o2 sats started to drop.No patient damage.".No patient injury.Sample is available with sales rep.Lot number is unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).A sample was received for evaluation.The sample was visually inspected and was observed that the bag separated from the mask and traces of adhesive remained on the bag which is evidence were the tape was placed.Measurements showed that it was out of spec which caused a poor assembly between the bag and the connector.However, without a lot number it is not possible to review the batch history record for any extraordinary events that could have contributed to the defect reported.This defect was determined to be caused by the operator¿s misplacement of the green tape on to the oxygen mask.Quality personnel perform a visual sampling of this product according to procedure of inspection.The probable root cause is that our operative personnel failed to follow manufacturing procedure and the oxygen mask may have been misassembled.A corrective and preventative action plan has been initiated.All production and quality personnel were notified of this failure reported and received additional training in the manufacturing procedure.In addition, work instructions (process analysis sheet) are being created for this product in order to show how the process should be followed and this will be placed in the work stations.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Corrected data: pt identifier, adverse event and/or product problem, outcomes attributed to adverse events, type of reportable event, investigation completion date.Additional info: sample receipt date.(b)(4).

• Brand Name: MASK NON-REBREATHER ADULT W/SAFETY VENT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• 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: 4583086
• MDR Text Key: 5479424
• Report Number: 8030673-2015-00134
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 001211-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention