MAUDE Adverse Event Report: COVIDIEN PALINDROME HSI 28/45 KIT VT CE; DIALYSIS CATHETER

Model Number 8888145049C

Device Problem Air Leak (1008)

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

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/23/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on(b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer reports the silver ion part of the catheter gets what looks like bubbles.The catheter was placed on (b)(6) 2016 and then removed and replaced on (b)(6) 2016.The product is cleaned with hospital alcohol.

Manufacturer Narrative

Please see section a2 and a3 for additional patient information.There was no patient harm or medical intervention.

Manufacturer Narrative

Submit date: 02/09/2017.The device history record (dhr) was reviewed and no deviations related to this failure mode were found.No changes were identified that may impact the product/process related to reported condition during a period of six months prior to manufacturing date.Quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.The physical sample involved in the reported incident was returned for analysis and investigation; it consisted in one palindrome his catheter.The catheter came inside a generic plastic bag and showed signs of use (remains of blood and a yellowish color in the hub).Visual inspection was performed; it was observed that the catheter was cut 8.5 cm approx.Below the cuff, and it was observed that a section of the am sleeve have bubbles.Based on previous information the most probable root cause for this defect is customer misuse (wrong cleaning agent used or patient conditions).No complaint triggers or trends were identified, therefore further corrective or preventive actions were not 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: PALINDROME HSI 28/45 KIT VT CE
• 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 solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5974107
• MDR Text Key: 55783980
• Report Number: 3009211636-2016-00408
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145049C
• Device Catalogue Number: 8888145049C
• Device Lot Number: 1518000132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR