MAUDE Adverse Event Report: VYAIRE MEDICAL NEB ADAPTER F/1000ML BOTTLE; NEBULIZER ADAPTER

Model Number 3D0868

Device Problem Connection Problem (2900)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical complaint number: (b)(4).At this time, vyaire medical has not received the suspect device for evaluation.

Event Description

Customer reported: as per rt, supplies for high humidity face mask oxygen delivery required for treatment.Airlife nebulizer cap required for treatment, retrieved with sterile water bottle.Given to rt.Rt informed staff that supplies did not fit together.Second bottle retrieved.Still did not fit.Second airlife nebulizer cap retrieved, also did not fit.Staff had to go to for a third airlife nebulizer cap and sterile water bottle.

• Brand Name: NEB ADAPTER F/1000ML BOTTLE
• Type of Device: NEBULIZER ADAPTER
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8466073
• MDR Text Key: 141211028
• Report Number: 8030673-2019-00036
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403180477
• UDI-Public: (01)10885403180477(10)0001201314
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: OBSOLETE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3D0868
• Device Catalogue Number: 3D0868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other