MAUDE Adverse Event Report: VYAIRE MEDICAL, INC BABY SAFE HYP INF,.5L BAG,0-35CMH20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 5404L1

Device Problem Fracture (1260)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Vyaire has received the affected sample.The sample has been shipped to the contracted third party decontamination facility and from there will be sent to the (b)(4) facility for further testing.Once the investigation has been completed a supplemental embr will be submitted.

Event Description

Customer reported a during patient use instance."i had a patient in cicu that was having plugs in her lung.I was called to the bedside by the registered nurse because the patient was not oxygenating and her spo2 was falling" the bag being used was accidently snagged on another piece of equipment during use and it came a part.The end-user confirmed that there was no quality issue with that bag it was user error that it became snagged and pulled apart.The end-user was unable to put the device back together quickly so a second device was called for.One was brought to the bedside and a crack was observed on the peep valve.The end-user opted to use the bag because the infant was further decompensating.The end-user stated that the infants "pressures were all over the place" and a third bag was called for.When the third bag arrived at the bedside it was used without further incident and the infant recovered.

Manufacturer Narrative

Device evaluation: the contaminated device was received at the third-party decontamination facility on (b)(6) 2017.The sample was decontaminated and then shipped out to the manufacturing facility in (b)(6) for further evaluation.The "cracked" condition could be confirmed by visual inspection.The "cracked" condition was noted on the apl cap.This part is molded and supplied to vyaire by (b)(4).Vyaire's manufacturing facility assembles the component to the sub-assembly by using a pneumatic press.The personnel assembly processes and inspection test methods have been reviewed and evaluated and are believed to not contribute to the observed defect.Vyaire has completed a thorough evaluation of the personnel assembly process, manufacturing process, and functional testing has been performed on the returned sample device.A device history record was also performed for the reported lot number, and no issues were found.Incoming inspection is being performed per procedure by receiving, looking for any cosmetic defects on the supplied components for parts used in this finished good.The assembly process was reviewed in detail, and the components are being assembled per procedure using a pneumatic press.Vyaire completed additional testing on the pneumatic press attempting to replicate the failure in production.The failure was not reproduced.According to the investigation the defect is not related to internal processes based on current findings.Vyaire has initiated a capa, along with the initiated scar that has been issued to the supplier.Additional studies and testing are underway at the supplier level in partnership with vyaire.At this time no root cause has been identified at this time.

• Brand Name: BABY SAFE HYP INF,.5L BAG,0-35CMH20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 7100057
• MDR Text Key: 94254129
• Report Number: 8030673-2017-00392
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5404L1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 02/22/2018
• 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
• Patient Outcome(s): Required Intervention