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).The catalog number has been corrected to 2414.The device history record of batch number 74k1401208 has been reviewed and no issues or discrepancies were found which could potentially relate to the reported complaint.The dhr shows that the product was assembled and inspected according to our specifications.The actual sample was not available; however, the customer returned a representative sample for evaluation.A visual exam was performed and no defects were observed.Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.The customer returned a representative sample only.The representative sample was visually examined with no defects or anomalies observed.A dhr review was performed on the lot number reported with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of kinked tubing could not be determined based upon the information provided and without the actual complaint sample.

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: 4871217
• MDR Text Key: 18029262
• Report Number: 3004365956-2015-00167
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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