MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN NEOFORCE RESUSCITATION KIT; INFANT RESUSCITATION KIT T-PIECE CIRCUIT 1.9M WITH ROUND MASKS SIZES 0 + 1

Catalog Number NF-155-NTU

Device Problem Blocked Connection (2888)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

A different mask from the same part number/family was used to no ill effect.

Event Description

Opening on the connector portion of the mask has a thin membrane that won't allow air/o2 to enter.This was not noticed as the mask/t-piece would allow to check peep due to pressure created by membrane on the mask.

• Brand Name: NEOFORCE RESUSCITATION KIT
• Type of Device: INFANT RESUSCITATION KIT T-PIECE CIRCUIT 1.9M WITH ROUND MASKS SIZES 0 + 1
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• MDR Report Key: 11327015
• MDR Text Key: 233275236
• Report Number: 3006061749-2021-00003
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• PMA/PMN Number: K103833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/15/2021

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 Catalogue Number: NF-155-NTU
• Device Lot Number: 201001687
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2020
• 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): Other