MAUDE Adverse Event Report: COVIDIEN PALIND 19/36 SLOT KIT W/VT; DIALYSIS CATHETER

Model Number 8888145039

Device Problem Hole In Material (1293)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/19/2015

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 01/05/2016 that a customer had an issue with a dialysis catheter.The customer reports 30 minutes after the hemodialysis treatment began, blood was noticed on the venous branch of the catheter.There was a very small hole on the transparent tube of the venous branch.The patient was re-transfused on the arterial side.The line was clamped, the doctor was advised, and antibiotic was administered as prophylaxis.A change of the catheter was requested and performed on (b)(6) 2015.There were no patient injuries or ill effects.The catheter was originally implanted on (b)(6) 2015.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There was no non-conformance records (ncrs) related to the reported issue for the involved lot.No changes were identified that may impact the product or process related to the reported condition during a period of six months prior to the manufacturing date.The product sample was returned for investigation, it consisted of a palindrome catheter that was received inside a plastic bag and the catheter presented signs of use.A visual inspection was performed and a pinhole was found on the venous extension.The clamps were reviewed and did not show any issues or rough edges.In order to confirm the reported issue, functional testing was performed.As a result, bubbles were detected; they were coming out from a pinhole in the venous extension.The lumen related to the arterial extension did not show bubbles during the test.In addition, a photo was provided by the customer; visual evaluation of the picture revealed a drop of an unknown liquid coming out from the venous extension, additionally blood residues were identified on the clamp of the blue extension.A diagram was used to determine the potential causes for this event.Based on the fishbone diagram, the possible causes were identified: material: defective material: per procedure, manufacturing performs 100% pressure (leak) testing.Additionally, the device history record review does not reveal any deviation of the current procedure that might have contributed to the reported condition.(discarded) 2) man.Operator failed to follow process and inspection procedures: per procedure, manufacturing performs 100% pressure (leak) test.Additionally, the device history record review does not reveal any deviation of the current procedure that might have contributed to the reported condition.The issue was not identified prior to use, and functioned as intended for the reported amount of time.(discarded) customer misuse (over bending, excessive force, and sharp object): as per the instructions for use (ifu), the customer has to perform a visual inspection before using the device.The ifu states: 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 continues, 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 sample was received damaged after being in use for a period of approximately 14 days, this is evidence that the catheter was manipulated; this manipulation could be associated to the damaged found in the extension; therefore it can be concluded that the reported condition could be related to the use of a sharp object or rough edges after catheter insertion.(not discarded).No potential causes were identified under the machine, method, or measurement categories.(discarded) the reported condition has been confirmed.The product sample was returned to the manufacturing site for review.Based on the available information and the results 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 procedures; therefore the most probable root cause can be considered as misuse.This issue 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 corrective and preventative action (capa) and health hazard evaluation (hhe) was opened to address this failure mode in this product family.No complaint triggers or trends were identified; further actions are 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, 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: PALIND 19/36 SLOT KIT W/VT
• 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: 5351890
• MDR Text Key: 35381458
• Report Number: 3009211636-2016-00024
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

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: 8888145039
• Device Catalogue Number: 8888145039
• Device Lot Number: 1506800099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1