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

Model Number 8817748001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/20/2015

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 errhysis (slow bleed) in the joint of the catheter when conducting dialysis, therefore dialysis failed.The catheter use was less than 2 months.There was no patient injury.

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.Multiple attempts have been made for additional clarification on the incident reported.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

The device history record (dhr) was reviewed for the lot number 204710x, and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue for the involved lot.A sample was returned for evaluation.The sample consisted of one kit incomplete of product 36cm perm cath kit x5.The kit incomplete came inside a plastic bag and it was an open kit.Visual inspection was performed and revealed that the catheter did not have the adult blue adapter and the others components of the kit incomplete that was returned did not present visual defects.Additionally, with the sample returned, it was found to be a different lot, 135016x.The returned catheter was used to repair the adapter related to this event, the catheter itself was still in use.The returned product was not associated with the event reported.The sample returned was submitted to an underwater test.Both lumen extensions did not show bubbles during the test.Based on the reported event, it was determined that the failed part on the original catheter was the blue adapter.The sample related to the product reported on this complaint was not received and no issues were identified on the catheter returned.As per the instructions for use (ifu), it is necessary to perform a visual inspection before using the device.Do not use the catheter if it is crushed, cracked, cut or otherwise damaged.Over tightening the catheter connections can crack some adapters.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that the product was manufactured according to specifications and it functioned as intended for the reported amount of time; therefore it can be concluded that the adapter was more likely damaged during use.The most probable root cause is over tightening the adapter.Although this event has not been determined to be manufacturing related, luer adapters leaking is being addressed through a corrective and preventive action (capa).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 nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• 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: 4815430
• MDR Text Key: 5924993
• Report Number: 3009211636-2015-00255
• 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,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• 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: 204710X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1