MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO

Model Number IPN049872

Device Problem Disconnection (1171)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that: the air cushion face mask got detached from the breathing circuit before use on a patient.Therefore, both the mask and the breathing circuit was replaced with a new units.

Manufacturer Narrative

Qn#(b)(4) the customer returned only component 10741 elbow w/port, 22mm x 15mm from catalog number 7140, breathing circuit, anesthesia, adult, 48 in w/3 ltr.During the visual inspection, it was observed that the component is not damaged.A dimensional inspection of the elbow component was conducted and the part was found to be within specification.Functional testing could not be performed as the complete device was not returned.Based on the returned sample, the complaint could not be confirmed.During the visual exam, no issues were found with the component.The complete sample is needed to perform a proper investigation and establish a root cause.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: the air cushion face mask got detached from the breathing circuit before use on a patient.Therefore, both the mask and the breathing circuit was replaced with a new units.No patient involvement.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15352479
• MDR Text Key: 305697286
• Report Number: 3004365956-2022-00067
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 14026704641410
• UDI-Public: 14026704641410
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN049872
• Device Catalogue Number: 7140
• Device Lot Number: 74K2100958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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