MAUDE Adverse Event Report: CAREFUSION/BD RESUS, PED W/MASK, 40" TBG, P/O, 6/CS; MANUAL EMERGENCY VENTILATOR

Catalog Number 2K8008

Device Problem Fracture (1260)

Patient Problem Hypoxia (1918)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission (b)(4) has reached out to customer to provide the complaint device for further investigation.(b)(6) 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

Medwatch report #2300170000-2016-8023 states: while getting off the elevator to transport the patient to the room, the patient coughed and it was noted that her et tube had been displaced.The crna and surgeon then began to try to ventilate the patient with mask/resus bag and it was then noted that the mask was in the trash and when obtained it appeared to be stepped on because there was a large hole that was not there prior.This is what the patient safety report stated: upon transport to the picu from outpatient surgery, the patient's endotracheal tube became dislodged; when the patient coughed.The patient and team were preparing to come off the elevator into the picu when the tube was noted to be in place.At that point the patient was bagged with mask/resus bag, and immediately ran into room where picu staff was waiting.Upon trying to bag the patient, it was noted that the mask had a crack in it and therefore adequate air exchange was not happening, so a new mask was exchanged out.The picu staff was then able to gain adequate spo2, and they were able to re-intubate the patient.

Manufacturer Narrative

Results of investigation: the affected sample was received for investigation, and during our visual inspection the cracked condition was observed; therefore the reported failure mode was confirmed.Carefusion/bd was unable to review the device history record as the lot number was unavailable.Two years of complaints were reviewed and no trend was detected.Upon review of our manufacturing procedure we did not find any deficiencies that would lead to this type of failure.Based on the investigation carefusion/bd is unable to determine a root cause; there is no evidence that the cracked condition on the mask occurred during the manufacturing process.It is probable that this may have happened outside the manufacturing process; such as during shipping and handling.

• Brand Name: RESUS, PED W/MASK, 40" TBG, P/O, 6/CS
• Type of Device: MANUAL EMERGENCY VENTILATOR
• 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
• MDR Report Key: 5854987
• MDR Text Key: 51442997
• Report Number: 8030673-2016-00202
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2K8008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention