MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number RT330

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device 1: lot: 2101372324, dom: 05 nov 2020, udi: (b)(4).Device 2: lot: 2101235192, dom: 07 aug 2020, udi: (b)(4).Method: the two complaint rt330 optiflow junior tubing kits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the photograph provided revealed that the oxygen monitoring port cap of the pressure manifold of one of the subject devices was missing.However, it is unclear if the packaging of the rt330 optiflow junior tubing kits was sealed at the time of this reported event.Conclusion: we are unable to determine the cause of the reported event.All rt330 optiflow junior tubing kits including the pressure relief valve are pressure and leak tested prior to being released for distribution.The pressure and leak test is followed by a visual inspection of the devices.Any circuits or pressure relief valves that fail are rejected.The user instructions that accompany the rt330 optiflow junior tubing kit state the following: check all connections, caps and/or plugs are tight before use.Patient monitoring is recommended.Discard product if the pressure relief valve is damaged or damage is suspected.Discard product if the blue cover on the pressure relief valve has been removed or is missing.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility that the cap of the pressure relief manifold was missing from two rt330 optiflow junior tubing kits.There was no patient involvement.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 12022019
• MDR Text Key: 267942480
• Report Number: 9611451-2021-00691
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 04/01/2021

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: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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