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

Model Number 004081-A

Device Problems Melted (1385); Temperature Problem (3022)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Customer reported via telephone call: mr.(b)(6)'s had a customer reported item: (b)(6) became hot and experienced melting.

Manufacturer Narrative

(b)(4).Results of investigation: 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 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.A review of the documentation of internal manufacturing device history records could not be reviewed due to no lot number being reported.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.

• 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 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4039247
• MDR Text Key: 4800588
• Report Number: 8030673-2014-00123
• 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
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 004081-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1