MAUDE Adverse Event Report: TELEFLEX MEDICAL RESUS PEDS W/ TUBE RSVR MASK; VENTILATOR, EMERGENCY, MANUAL

Catalog Number 45367

Device Problem Deflation Problem (1149)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Reported issue: the cuff was deflated.There were no clinical consequences for patients.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

Qn#(b)(4).The manufacturing site, galemed, completed the inspection after receiving the returned sample on 21 mar 2023.The actions taken were as follows: 1.There are no related abnormal production, incoming, and inspection records about lot 191007 and lot 200824.2.Appearance inspection of customer return samples: appearance of the two returned samples is relatively in a good and intact state, not been scratched or broken.3.Air volume test of the return samples: volume value of xtf0001 lot 200824 air cushion mask sample is 2.15 (acceptance range 9.5-16.5mm).Volume value of xtf0101 lot191007 is 2.14 (acceptance range 8.3-13.3mm).So, both samples are indeed unqualified.A review of the air cushion mask standard manufacturing procedure (smp) was completed, and it could be confirmed that all air cushion masks were in a good state upon production release.Since sample of lot191007 has exceeded the period of validity during clinical usage period, there is a risk for a leak.And considering the material of returned samples are pvc, factors such as products squeezing each other heavily and uncontrolled storage and transport condition, may lead to air molecules spillage away through the air cushion masks' surface.For these reasons, a root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported issue: the cuff was deflated.There were no clinical consequences for patients.

• Brand Name: RESUS PEDS W/ TUBE RSVR MASK
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16570171
• MDR Text Key: 311709768
• Report Number: 3011137372-2023-00058
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: 45367
• Device Lot Number: 191007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED