MAUDE Adverse Event Report: CAREFUSION CONNECTOR U/ADAPIT STR NO BASE 50/CS; CONNECTOR, AIRWAY (EXTENSION)

Model Number 004078-A

Device Problem Melted (1385)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Sales rep reported via telephone to airlife sales support: customer complaint that the heater they are using is melting the port.  customer states this has happened 4 times in the last month.  customer first aware of this issue (b)(6) 2014.The following complaints were opened to capture the other three incidents.(b)(4).  additional information received via telephone on (b)(4) 2014: writer called customer ((b)(6)) but staff stated he is out of the office till monday.Writer spoke to rt ((b)(6)) who stated that she was aware of the issue.She stated the product is used for cpap/bipap oxygen bleed in which has heated humidification.When asked how often the product is changed, she stated as needed.The melting conditions were observed by patient service technicians.

Manufacturer Narrative

(b)(4).Investigation summary: no sample was returned for evaluation.Therefore, the reported condition could not be confirmed.Due to similar reports reported, it was concluded that the ports from the adapter of product 004078 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 device history record review for the lot reported that could result in the reported condition.At this time there is no evidence that confirms that carefusion operative personnel is 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 004078 adapter should be changed every 30 days.Carefusion will continue to monitor and trend this report.

Manufacturer Narrative

(b)(4).Additional information: on august 22, 2014, the manufacturing plant received a sample returned for evaluation.The sample was submitted to ir scan and it was concluded that the ports were exposed to dehp.Therefore, the deformation concluded to be by long term use with pvc connector on the ports of the adapter.

• Brand Name: CONNECTOR U/ADAPIT STR NO BASE 50/CS
• 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 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3995799
• MDR Text Key: 15366775
• Report Number: 8030673-2014-00118
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: 004078-A
• Device Lot Number: 0000637524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• 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