MAUDE Adverse Event Report: TELEFLEX HUDSON CORR-A-FLEX TUBING, 100 FT. ROLL; CORRUGATED TUBING

Catalog Number 1680

Device Problems Material Too Rigid or Stiff (1544); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges the inability to secure that cut ends of the device to their delivery system and an increase in stiffness to the device.The customer reports of a delay in treatment to the pt.No pt injury reported.The pt condition is reported as fine.

Manufacturer Narrative

The device history record (dhr) of nl lot #02a1400363 was reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the pt was assembled and inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.Customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.However current production was verified to identify any issue that can lead to the reported defect and no issues were found since wall thickness and internal diameter were found within specification, also a leaking test was performed on these samples on fixture to verify the functionality on the connections and no problems were presented during the performed verification.If the defective sample becomes available this investigation will be updated with the evaluation results.As a corrective action r&d engineering department will be notified about the complaint received.The lot mentioned in this complaint is related to a resin change project performed (b)(6) 2013.A visual, functional dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.

• Brand Name: HUDSON CORR-A-FLEX TUBING, 100 FT. ROLL
• Type of Device: CORRUGATED TUBING
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3847684
• MDR Text Key: 4685026
• Report Number: 3004365956-2014-00136
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1680
• Device Lot Number: 02A1400363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1