MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 22MM SGL HTD LIMB CIRC KIT; HUMIDIFIER NEBULIZER KIT

Catalog Number 870-19KIT

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received for evaluation at the time of this report.The device history record (dhr) of batch number 74a1801249 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.If the device becomes available at a later date this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the device is not allowing water to flow during use.Customer reports constantly having to prime the water bottle to create flow.Alleged issue reported as occurred during use.Customer reports no patient injury or consequence.Patient condition reported as "fine".

• Brand Name: HUDSON 22MM SGL HTD LIMB CIRC KIT
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7534936
• MDR Text Key: 109239848
• Report Number: 3004365956-2018-00157
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: 870-19KIT
• Device Lot Number: 74A1801249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• 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