MAUDE Adverse Event Report: COVIDIEN MANUFACTURING DUAL LUMEN INSERTION TRAY; PERIPHERALLY INSERTED CENTRAL CATH

Model Number 43311

Device Problems Leak/Splash (1354); Compatibility Problem (2960)

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

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dual lumen peripherally inserted central catheter (picc).The customer reports that the picc began leaking just below the molded strain relief of the secondary extension tubing (purple extension).Betadine was used to clean the skin area and the area was completely dried prior to insertion.The catheter was not difficult to handle during insertion and was not difficult to secure.The picc was inserted on (b)(6) 2014.Each line was flushed on a regular basis.The 2nd line is maintained with continous fluid.Normal saline / heparin was used to flush the lines.The picc was not in long enough to be cleaned.The picc was removed on (b)(6) 2014.The device was replaced with another picc on (b)(6) 2014.The status of the patient is stable.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The manufacturing lot number associated with this complaint was 1409400238; it was released on (b)(6) 2014.The device history record (dhr) review indicated that there were no quality issues and no deviations related to this failure mode found.There are no non-conformances related to the reported issue.The sample was provided and based on examination under a microscope, a hole in the catheter was found below the butterfly.It is important to mention that the instructions for use states: do not use a sharp clamp or instrument to handle the catheter as a minor cut could tear or break the catheter.It further states, do not stretch the catheter as too much tension could tear the catheter.Based on the investigation, it is likely the device was damaged during use as the catheter was found with a cut below the butterfly.The reported issue has been confirmed with a cut below the butterfly.With the available information, the most probable root cause could be considered misuse (leak could be caused due to a sharp object).No additional actions are required at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing facility.As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: DUAL LUMEN INSERTION TRAY
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATH
• Manufacturer (Section D): COVIDIEN MANUFACTURING; alajuela 0000 ; CS 0000
• Manufacturer (Section G): COVIDIEN MANUFACTURING SOLUTIONS SA; edificio 820 calle #2 zona france coyol; alajuela 0000 2010; CS 000020101
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048-0000 ; 5082616283
• MDR Report Key: 4047675
• MDR Text Key: 4864592
• Report Number: 3009211636-2014-00039
• Device Sequence Number: 1
• Product Code: DQO
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43311
• Device Catalogue Number: 43311
• Device Lot Number: 140940238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1