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  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.From the pictures that was submitted, the defect reported by the customer "broken/cracked - double swivel connector" was confirmed.However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.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

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

Manufacturer Narrative

(b)(4), the customer returned one unit 5-15401 sher-i-swiv/fo for investigation.Only a cobb connector (which is a part of the swivel connector) was returned.It could not be determined if the cobb connector belonged to the bronchial or tracheal swivel connector.The et tube, suction catheters, other swivel connector, and y connector were not returned.The returned connector was visually examined with and without magnification.Visual examination of the returned sample revealed that the cobb connector was broken on the 15mm side.The cobb/swivel connector is a component purchased from a supplier.A capa was previously opened to further investigate this issue.Corrective actions were implemented under the capa on 15apr2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

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: 15649767
• MDR Text Key: 306069876
• Report Number: 3003898360-2022-00614
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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