MAUDE Adverse Event Report: COVIDIEN PALINDROME - P(HSI) SP VT 23CM; DIALYSIS CATHETER

Model Number 8888123409P

Device Problem Hole In Material (1293)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 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 reported that the palindrome catheter was placed on (b)(6) 2016 and was removed immediately at the time of insertion when they realized there was a hole.The catheter was pulled and replaced with a different catheter at that time.The procedure was not held up or extended because of the issue.No surgical intervention was needed.

Manufacturer Narrative

The customer reported that a hole was discovered in the hub of the catheter.

Event Description

The customer reported that a hole was discovered in the hub of the catheter.

Manufacturer Narrative

It was originally reported that the customer had an issue with item 8888541023p; however the correct item code is 8888123409p.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There were no non-conformances related to the reported issue.The product sample was received inside a generic plastic bag.The catheter presented signs of use (remains of blood).After visual inspection, one cut in the venous extension in the area where the hub connector meets the silicon extension was found.This cut looks irregular.As per the instructions for use (ifu), it is necessary to perform a visual inspection prior to using the device.Do not use the catheter if it is crushed, cracked, cut or otherwise damaged.Clamping the catheter repeatedly in the same spot could weaken the tubing.Exercise caution when using sharp instruments near the catheter.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 defect was not identified prior to use, this kind of defect would be detected during leak test.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time.Moreover, 100% devices are inspected for leaks or cuts in the extensions per procedure; therefore the most probable root cause can be considered as misuse; the reported condition was more likely caused due to the improper use of sharp objects, repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.No complaints triggers or trends were identified; therefore corrective or preventive actions are not required at this time.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.Manufacturing performs 100% leak testing 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 purposes.

• Brand Name: PALINDROME - P(HSI) SP VT 23CM
• 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; +1(508)452-4811; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5489381
• MDR Text Key: 40263392
• Report Number: 3009211636-2016-00113
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2016

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: 8888123409P
• Device Catalogue Number: 8888123409P
• Device Lot Number: 1530800180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2016; 04/11/2016; 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1