MAUDE Adverse Event Report: COVIDIEN 36CM PERM CATH KIT X5; DIALYSIS CATHETER

Model Number 8817748001

Device Problem Material Perforation (2205)

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

Event Date 02/03/2015

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 the silicone extension tube was perforated.The catheter was removed and replaced with a new one.

Manufacturer Narrative

(b)(4).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 for evaluation.The sample returned consisted of one quinton permcath dual lumen catheter, 36 cm, product code 8817748001 which came inside a plastic bag and presented signs of use (cuff with residues of blood and the catheter was cut approx.3 cm below the cuff).Visual inspection was performed and revealed that the catheter had a hole on the extension tube near to red adult adapter.The most probable root cause is that the leak was more likely caused by misuse such as improper inappropriate use of sharp objects, repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection, leak testing and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing and a 100% visual inspection at the final stage of production, which would identify this issue in the catheter assembly.No additional actions are required.This complaint will be used for tracking and trending purpose.

• Brand Name: 36CM PERM CATH KIT X5
• 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: 4553299
• MDR Text Key: 5526846
• Report Number: 3009211636-2015-00138
• 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,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 208921X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• 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