MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON HUMIDIFIER ADAPTOR, 040 SHELF PAK, FRENCH

Catalog Number 000-40F

Device Problems Disconnection (1171); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The customer alleges that the nurse found the aquapak disconnected from the connector; the connector was split at the level of the small fin's slot.No report of a pt injury.

Manufacturer Narrative

(b)(4).It is unk if the device is available for evaluation.A visual functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Customer supplied an adaptor part number without the lot number.The water product part number and lot number were not supplied by the customer.No device history record review could be performed.No sample available from the customer to investigate.Teleflex will monitor feedback from the customers on issues related to aquapak disconnected from connector found at inspection on water bottle products.The complaint cannot be confirmed.Root cause unk.

• Brand Name: HUDSON HUMIDIFIER ADAPTOR, 040 SHELF PAK, FRENCH
• Type of Device: HUMIDIFIER ADAPTOR
• Manufacturer (Section D): TELEFELX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFELX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4788228
• MDR Text Key: 15963942
• Report Number: 1417411-2015-00100
• Device Sequence Number: 1
• Product Code: BTT
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000-40F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• 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