MAUDE Adverse Event Report: CAREFUSION NASAL PRONGS; CIRCUIT BREATHING/CAI

Model Number NASAL PRONGS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 07/29/2014

Event Type  Injury  

Event Description

The following description of the event was documented by a carefusion technical support specialist in response to a telephone call from a carefusion clinical operations consultant.[(b)(6)] called.He said that he has been working with this account because of some issues they have been having with the infant flow lp disposables.He said he was told they have had nasal septum skin breakdown with the lp nasal prongs on 2 patients.He states he has been in there already for some retraining and there is a rep in there now for hands on training as well.He has offered the carefusion training portal as well and they have pushed that aside.He states he spoke to [(b)(4)] and she has asked him to log the complaint with technical support.He states that he has been in contact with [(b)(4)], neonatal clinical nurse specialist and it has been hard to get information out of her.She will most likely refer us to the safety officer.".

Manufacturer Narrative

The user facility did not submit a user facility report to the manufacturer.Nasal irritation, septal distortion, skin irritation and pressure necrosis are known complications of ncpap therapy and this is mentioned in the carefusion infant flow lp ncpap systems instructions for use.As the carefusion infant flow lp ncpap system is relatively new to the market, the user facility's possible lack of experience with this system may have been a contributing factor in the reported event.On (b)(4) 2014 the carefusion clinical operations consultant reported that the user facility agreed to have their staff watch the infant flow lp ncpap system training course video on the carefusion learning portal and follow carefusion's recommendations regarding the appropriate use of the carefusion infant flow lp ncpap system.

Manufacturer Narrative

This supplemental report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.Associated event, 2021710-2014-00046.

Event Description

This is 1 of 2 reports for the same event.

• Brand Name: NASAL PRONGS
• Type of Device: CIRCUIT BREATHING/CAI
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 1100 bird center dr.; palm springs, CA 92262 ; 7149227830
• MDR Report Key: 4054714
• MDR Text Key: 4859066
• Report Number: 2021710-2014-00045
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NASAL PRONGS
• Device Catalogue Number: 777XXXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/29/2014
• Event Location: Hospital
• Date Manufacturer Received: 08/29/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other