MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 02634-01

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.After review of pictures provided by the customer, it was confirmed the defect reported by the customer "broken/cracked - double swivel connector".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause and 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

It was reported that "the connector was found cut in the packaging".No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer returned one unit 02634-01 sher-i-bronch accessory pack for investigation.The y connector and both swivel connectors were returned.The returned connectors were visually examined with and without magnification.Visual examination of the returned samples revealed that the bronchial swivel connector was broken on the 15mm side.The swivel connector is a component purchased from a supplier.A non-conformance was previously opened to further investigate this issue.Corrective actions were implemented under the non-conformance on 08jan2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

Event Description

It was reported that "the connector was found cut in the packaging".No patient involvement reported.

• Brand Name: HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK
• 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
• MDR Report Key: 13906838
• MDR Text Key: 295047380
• Report Number: 3003898360-2022-00076
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/06/2022

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 Catalogue Number: 02634-01
• Device Lot Number: 73M1900235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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