MAUDE Adverse Event Report: COVIDIEN PALINDROME 55/72 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145018

Device Problem Hole In Material (1293)

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

Event Date 03/12/2015

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 reports that at the beginning of the treatment, upon irrigation of the cvc branch with syringe nacl 0.9%, there was a blood drop at the arterial branch of the cvc and, upon irrigation of the venous branch, presence of a blood drop also.We noticed 2 breaks of the 2 branches of the cvc, 2 microscopic holes on the 2 transparent tubes of the branches.Clamped the lines and the catheter was removed on (b)(6) 2015.Catheter was installed on (b)(6) 2015.No patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The product sample was returned inside a generic plastic bag.The sample consisted of one 14.5 fr tal palindrome w/slots catheter, 55 cm implant length, 72 cm overall length.After visual inspection, signs of use was identified - the clamps appear to have blood residue.Additionally, holes were found on both catheter extensions tubing (arterial and venous).During the functional test (underwater test), bubbles were detected coming out of both tubing extensions.Two photos were also provided by customer.The arterial and venous extension section of a catheter can be noticed on the images and a droplet of liquid (possibly water) can be observed on the arterial and venous extensions; however based on the images it is not possible to confirm if they are coming out from the extensions, or if they are just at the outer side on them.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter or components if they appear damaged or defective.Clamping the catheter repeatedly in the same spot could weaken the tubing.Change the position of the clamp regularly to prolong the life of the tubing.Avoid clamping near the adapter and hub.Catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, cuts, etc., which could impair its performance.The most probable root cause can be due to the improper use of sharp objects.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 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.

• Brand Name: PALINDROME 55/72 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 hamsphire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4629702
• MDR Text Key: 20015529
• Report Number: 3009211636-2015-00172
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145018
• Device Catalogue Number: 8888145018
• Device Lot Number: 329043X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR