MAUDE Adverse Event Report: AOK TOOLING LIMITED ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number CSC300

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time the device has not been received for evaluation.If the device becomes available, an investigation will be completed and a follow up emdr will be submitted.

Event Description

Under investigation it was stated via email "hey (b)(6), i left one of the new ett t-connector pieces in your mailbox over the weekend, and i planned on writing an email but didn't get to it friday night.So this piece was on 843s tube and like three hours into my night shift i figured out it was broken.She was reintubated at some point friday day so it was only on there maybe like 8 hours.For the first two hours of my shift she was ringing off for volume issues and also i noticed her leak was bigger, and then after a bad episode when i went to put a saline bullet down her tube i noticed water was spraying out from somewhere and then while bagging her i could feel/hear some air coming from the tube as well.I noticed that the plastic part on connect that reads '3.5' was very easily spinning around the piece.With these being new i couldn't remember if that was supposed to happen but i figured not and i check another patients tube and theirs did not spin.So we removed the piece and put a new one on and when i opened the new pack i noticed that there was an o-ring around the bigger piece that connects onto the bottom connector piece and that it locked in very well with not much movement.So i assumed that the o-ring was missing in the defective piece and then miraculously when i weighed her at midnight and changed her sheets and outfit i actually found the o-ring in her bed.Must have fallen off when they opened the pack putting the new one when she was reintubated.No one knew what i was talking about when i was asking about the piece or knew if it was supposed to spin or not.When i told people about the o-ring people didn't know either.I think that even though it was a minimal effect it still caused issues with her being accurately ventilated because once changed the vent didn't alarm anymore.Was anyone injured? no.".

Manufacturer Narrative

(b)(4).Complaint sample was received and an evaluation was completed.The investigation into the reported failure was unable to duplicate the reported issue and therefore, the root cause of the reported issue could not be confirmed.A device history record (dhr) review could not be performed since the device was not returned and the lot number is unknown.

• Brand Name: ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): AOK TOOLING LIMITED; CH
• Manufacturer (Section G): AOK TOOLING LIMITED; long-tien village; keng zi town long gang distric; shen zhen ; CH
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6209166
• MDR Text Key: 63404598
• Report Number: 2050001-2016-00036
• Device Sequence Number: 1
• Product Code: CAI
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CSC300
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention