MAUDE Adverse Event Report: CAREFUSION CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD; CONNECTOR, AIRWAY (EXTENSION)

Model Number 004081-A

Device Problems Loose or Intermittent Connection (1371); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Oxygen port melted while being used in-line for cpap.Situation: 2-1/2¿ tube coming off of humidifier and then the 004081 is connected to that and then the cpap tube is on the other end.Patients said the oxygen tubing was loose on the oxygen port.

Manufacturer Narrative

(b)(4).Results of investigation: one sample and picture was received for evaluation.The sample was submitted to ir scan and it was concluded that the ports from the adapter of product 004081 were exposed to dehp.Pvc may cause the oxygen port to discolor or deform.In conclusion, the deformation could be caused by long term use with pvc connector on the ports of the adapter.No issues were found during the review of internal production records for the lot indicated that could result in the reported condition.At this time there is no evidence that confirms that carefusion operative personnel are contributing to this condition.Internal procedure calls for a visual inspection of this product prior to passing to the next stage.In addition, no issues were found with the materials or design of this product; the materials used for this catalog are validated.Based on the investigation, the most probable cause for the issue reported could be related to the long term use with pvc connector - plasticizers as dehp in flexible pvc may cause the oxygen port to discolor or deform.As an action plan, a modification will be implemented on the instructions for use of this product to include the statement, "up to 30 days" and "caution: devices designed to be attached to this adapter may contain flexible pvc.Plasticizers in flexible pvc may cause the oxygen port to discolor or deform.Periodically inspect the connection and replace product if damage or wear is observed¿.The 004081 adapter should be changed every 30 days.Carefusion will continue to monitor and trend this report.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• 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: 4215588
• MDR Text Key: 5002601
• Report Number: 8030673-2014-00132
• Device Sequence Number: 1
• Product Code: BZA
• 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
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 004081-A
• Device Lot Number: 0000588117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention