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

Model Number	IPN048992
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Complaint reports that: "blue plastic tube connected to the main body is loose.Not connected properly.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3003898360-2022-00614
• Device Sequence Number: 6036661
• Product Code: BZA
• UDI-Device Identifier: 14026704617378
• UDI-Public: 14026704617378
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/07/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown