MAUDE Adverse Event Report: COVIDIEN PALINDROME PRECISION 23CM SPORTPACK; DIALYSIS CATHETER

Model Number 8888123404P

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer states that the patient had to have their catheter exchanged after a noticeable leak through the extension tubing (small holes under the red port) during treatment.The catheter dwelled for approximately a month.

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.Visual inspection of the sample was performed and it was observed that the catheter presented signs of use (remains of blood) and a pin hole was found below red adapter.The returned sample was submitted to underwater test, bubbles were detected coming out from the arterial extension.The lumen related to the venous extension did not showed bubbles during the test.As per the instructions for use, 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 and 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.Sample returned presented a pinhole on the arteria; extension.The in-use time was unknown, however, the defect was not identified prior the insertion and the device functioned as intended for an undetermined amount of time.Additionally, manufacturing performs 100% visual inspection on catheter extensions and 100% pressure (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 procedures; therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use due to the 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.A qseas evaluation took place to assess this exceeded risk threshold, no further investigation activities or corrective actions were required and hhe evaluation hhe15-014 was opened.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 purposes.

• Brand Name: PALINDROME PRECISION 23CM SPORTPACK
• 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 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5004692
• MDR Text Key: 24261379
• Report Number: 3009211636-2015-00345
• 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: Followup
• Report Date: 08/12/2015

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: 8888123404P
• Device Catalogue Number: 8888123404P
• Device Lot Number: 1427300122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1