MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CORR-A-FLEX TUBING, 5'; CORRUGATED TUBING

Catalog Number 1517

Device Problems Fitting Problem (2183); Connection Problem (2900)

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

Event Date 02/11/2015

Event Type  malfunction  

Event Description

The customer alleges that the tubing was too stiff and the connection fell off during a patient procedure.No report of a patient injury or harm.

Manufacturer Narrative

Qn#(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review could not conducted since the lot number was not provided.No corrective action can be established since lot number was not provided and sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed due to the lack of sample and no lot number provided for investigation.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, this complaint will be updated with the evaluation results.

• Brand Name: HUDSON CORR-A-FLEX TUBING, 5'
• Type of Device: CORRUGATED TUBING
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4602855
• MDR Text Key: 22252593
• Report Number: 3004365956-2015-00083
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• 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