MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN SHER-I-SWIV/FO; CONNECTOR, AIRWAY (EXTENSION)

Model Number IPN048992

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Complaint reports that: "blue plastic tube connected to the main body is loose.Not connected properly.".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

Complaint reports that: "blue plastic tube connected to the main body is loose.Not connected properly." the issue was detected prior to use on a patient.

• Brand Name: SHERIDAN SHER-I-SWIV/FO
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15649765
• MDR Text Key: 306069775
• Report Number: 3003898360-2022-00622
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 14026704617378
• UDI-Public: 14026704617378
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN048992
• Device Catalogue Number: 5-15401
• Device Lot Number: 73J2000270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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