MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDOBRONCHIAL ACCESSORY PACK

Catalog Number 5-16142

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Extubate (2402)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The customer alleges having excessive difficulty ventilating through the endobronchial tube and experiencing a leak being the primary concern.While manipulating the circuit in an attempt to correct the problem, the 15mm double swivel connector assembly came apart.Intervention: the endobronchial tube was replaced with another one.Adequate ventilation of the patient was maintained throughout the procedure and no injury to the patient was detected.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A document assessment was conducted and no changes were required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.We will continue to monitor and trend of similar complaints.

• Brand Name: HUDSON SHER-I-BRONCH ACCESSORY PACK
• Type of Device: ENDOBRONCHIAL ACCESSORY PACK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; ranch oel descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4652920
• MDR Text Key: 15344318
• Report Number: 3003898360-2015-00237
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-16142
• Device Lot Number: 1411940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention