MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT TRACHE DIRECT INTERFACE; BZA

Model Number OPT870

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an opt870 tracheostomy interface was torn at the corrugated tubing where it meets the interface connection.The tear was discovered after patient use and the hospital confirmed that there was no patient harm.

Manufacturer Narrative

(b)(4).The opt870 interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's trach.Method: the complaint opt870 was returned to fisher & paykel healthcare (b)(4) and was visually inspected.Further information was also sought from the customer regarding handling and use of the subject interface.Results: visual inspection revealed that the tubing was pulled apart near the patient end connector.The tubing end connector and the grip were found to be partly pulled apart.A lot check was not performed as no lot information was provided.Conclusion: the customer had informed us that drugs were being nebulised but was not sure which drugs.Additionally they stated that it was possible that the tubing had been accidentally pulled apart.Based on the extent of the damage to the complaint interface it is likely that it has occurred as a result of excessive pulling force being exerted on the device.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and deformation.Any product that fails the visual inspection is rejected.Our user instructions that accompany the opt870 trache interface state: to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately.Do not crush or stretch tube.

• Brand Name: ADULT TRACHE DIRECT INTERFACE
• Type of Device: BZA
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 4513506
• MDR Text Key: 5407023
• Report Number: 9611451-2015-00078
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT870
• Device Catalogue Number: OPT870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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