MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR; CANNULA HUMIDIFICTION SYSTEM

Catalog Number 2414

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

The customer alleges that the tube is crimping/kinking at the column.No patient harm reported.

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.The lot number provided in this complaint is not a valid lot number for product 2416.No corrective action can be established at this time since the device sample or a picture of it is not available for evaluation.Customer complaint cannot be confirmed based only on the information 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 being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).Catalog # was corrected to 2414.The device history record of batch number 74k1401208 was reviewed and there were no issues or discrepancies found which could potentially relate to the reported complaint.No rejection reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the tube is crimping/kinking at the column.No patient harm reported.

• Brand Name: HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR
• Type of Device: CANNULA HUMIDIFICTION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4881634
• MDR Text Key: 21179544
• Report Number: 3004365956-2015-00183
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/23/2019
• Device Catalogue Number: 2414
• Device Lot Number: 74K1401208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2014
• 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