MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB ; BREATHING CIRCUIT

Catalog Number 780-24

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

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 received at our facility.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time.If device sample becomes available at a later date tis complaint will be re-opened.

Event Description

The customer alleges an occlusion issue due to crystallization of nebulized hypertonic saline within the neptune column on a ventilated pt.The occlusion caused a high pressure alarm on the vent.No pt harm reported.

• Brand Name: HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd. ; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4996520
• MDR Text Key: 23834856
• Report Number: 3004365956-2015-00230
• Device Sequence Number: 1
• Product Code: OFP
• 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
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• 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