MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD INFANT SINGLE-USE RESUSCITATOR + PRESSURE RELIEF + MASK

Catalog Number 038-73-940

Device Problem Insufficient Information (3190)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

This event is being reported under mdsap requirements where if an event takes place in a mdsap country, and that device is sold in the usa the event should also be reported to the fda.

Event Description

Event description as given to manufacturer "the nurse opened the pack to find no mask included.The pack was sealed and obviously sent to us in this state.Given the critical nature of the product thrust you can see the seriousness of this quality failure".No patient harmed reported, another one was used from a different crash cart.

• Brand Name: INFANT SINGLE-USE RESUSCITATOR + PRESSURE RELIEF + MASK
• Type of Device: INFANT SINGLE-USE RESUSCITATOR
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 16245801
• MDR Text Key: 308352164
• Report Number: 3006061749-2022-00029
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K181583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 038-73-940
• Device Lot Number: 190102853
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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