MAUDE Adverse Event Report: COVIDIEN PC PALINDROME 23/40 KIT W/SLOT; DIALYSIS CATHETER

Model Number 8888145059

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that there was air leakage when reverse bleeding in the vein channel was conducted.The patient reflected that the dialysis catheter suffered air leakage after being used for only two weeks.The doctor had removed the catheter and used a new catheter to replace it.The patient was involved without injury.The patient is in stable condition.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.This event will be handled through a formal corrective and preventative action and no additional actions are required.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.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.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.The sample consisted of one assembled catheter, 14.5 fr x 23 cm, palindrome pre-curved w/ slots.The catheter was cut below the hub.A visual inspection was performed and there were no issues found on the catheter.The sample was submitted to an underwater test and there were no bubbles found.The reported issue could not be confirmed.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes or cuts which could impair its performance.Do not use acetone on any part of the catheter.A probable root cause can be due to excessive force.Another possible root cause may be due to improper use of cleaning agents.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 non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending.

• Brand Name: PC PALINDROME 23/40 KIT W/SLOT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4704184
• MDR Text Key: 5712768
• Report Number: 3009211636-2015-00206
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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: Health Professional
• Device Model Number: 8888145059
• Device Catalogue Number: 8888145059
• Device Lot Number: 220825X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 37