MAUDE Adverse Event Report: COVIDIEN PALINDROME 23/40 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145015

Device Problems Hole In Material (1293); Fitting Problem (2183); Connection Problem (2900)

Patient Problem Extravasation (1842)

Event Date 04/22/2016

Event Type  Injury  

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) 2016 that a customer had an issue with a dialysis catheter.The customer reports that a hole was noticed on the blue branch of the catheter and lead to blood extravasation during the procedure.The change of the connection was difficult as the catheter is short.It was very difficult to fit the new connector.The catheter was applied on (b)(6) 2016 and was not punctured by a needle.On (b)(6) 2016 the hemoculture performed was positive.Another connector was used to stop blood extravasation and allow the procedure to be completed.Therapy treatment was conducted with use of vancomycin.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The sample was returned to the manufacturing site for analysis and investigation, it consisted of a palindrome catheter that was received inside a generic plastic bag; the catheter presented signs of use (dirt).Visual inspection was performed and it revealed one pinhole on the venous extension.The extensions did not present other marks.Additionally, the clamps were inspected and as a result defects or irregularities were not identified.An underwater test was performed and bubbles were detected coming out from the venous extension.The defect was not identified prior to insertion; this kind of defect would be detected during leak testing.The manufacturing process was reviewed to determine potential points of damage to the extension.The result was that the operations that are applied to the extension are light and the handling of the pieces is manually done, there is no use of sharp objects or other instrument that could generate the hole found on the sample received, therefore there are no elements encountered during the manufacturing process that could cause the reported condition.As per the instructions for use (ifu), the customer has to perform a visual inspection before 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, or cuts which could impair its performance.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.The most probable root cause can be that the defect was more likely caused during use, due to the inappropriate use of sharp objects, repeated clamping or other similar damage.

Event Description

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 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 23/40 KIT W/ SLOT
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5643276
• MDR Text Key: 44885201
• Report Number: 3009211636-2016-00202
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 1506100127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other