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

Model Number 8888145015

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer reports that dr.(b)(6) had inserted a palindrome catheter into the patient in (b)(6) 2015 but recently found that the dialysis machine alarmed for sucking air bubbles into the system.The doctor removed the catheter from the patient to investigate and found that the connection of the catheter and hub had been separated causing a hole which caused the leakage and air bubbles during dialysis.The patient was involved with no injury.

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.A visual inspection was performed and a hole was found on the joint of the catheter, below the hub.Additionally, the catheter was cut approximately 7 cm below the cuff.The sample was submitted to an underwater test.Bubbles were detected coming from both the arterial and venous lumens.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 possible root cause can be due to excessive force or improper use of cleaning agents.This event is being 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, 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 purposes.

• Brand Name: 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: 4946035
• MDR Text Key: 23025749
• Report Number: 3009211636-2015-00317
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/16/2015

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: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 106144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 24