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

Catalog Number 02634-01

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no update is required.It is necessary to receive the physical sample to perform a proper and thorough investigation to confirm the alleged defect.Customer complaint cannot be confirmed.Root cause cannot be determined.Corrective actions cannot be assigned.It is unclear if the device is available.Teleflex has requested this information.If the device sample becomes available, this report will be updated accordingly.

Event Description

Customer complaint states: "the swivel connector for the sheridan double-lumen tube system sheared off at connecting piece and was unable to be reattached.Alternate adaptor immediately used as replacement.No harm to patient".

• Brand Name: HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 8281655
• MDR Text Key: 134346884
• Report Number: 3003898360-2019-00085
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2019

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 Operator: No Information
• Device Expiration Date: 06/21/2023
• Device Catalogue Number: 02634-01
• Device Lot Number: 73F1800320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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