MAUDE Adverse Event Report: VYAIRE MEDICAL BABY SAFE HYP INF,1L,HOSE,60CMH20,ELBOW; FLOW-INFLATING RESUSCITATION BAGS

Catalog Number 5501HL1

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

At this time, vyaire medical has not received the suspect device.

Event Description

It was reported to vyaire that when the clinician attempted to bag a patient the screw valve came off and the physician was unable to use.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: BABY SAFE HYP INF,1L,HOSE,60CMH20,ELBOW
• Type of Device: FLOW-INFLATING RESUSCITATION BAGS
• 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: 8536582
• MDR Text Key: 146359671
• Report Number: 8030673-2019-00040
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5501HL1
• Device Lot Number: 0004069308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• 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