MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888123405P

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states there appeared to be a pin hole near the red arterial access port on the extension tube; air bubbles were seen prior to starting dialysis.

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 received for analysis and investigation.Visual inspection was performed and it revealed that the catheter presented signs of use.Additionally, the clamps were reviewed and as a result irregularities were not found.The arterial extension presented marks, as if there was the use of an instrument.In order to confirm the reported condition functional testing was required.An ishikawa diagram was used to determine the potential causes for this event.The reported condition has been confirmed.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 an undetermined 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.This issue was more likely damaged caused during use due to the use of strong cleaning agents, excessive force during of use, repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.No trends or trigger were identified.No harm was reported for this complaint and this is not a manufacturing/supplier related event, therefore, no further corrective or preventive actions are not deemed necessary at this time.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for (b)(4) 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states there appeared to be a pin hole near the red arterial access port on the extension tube; air bubbles were seen prior to starting dialysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; zona franca coyol; alajuela 0101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; zona franca coyol; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6427952
• MDR Text Key: 70757385
• Report Number: 3009211636-2017-05046
• Device Sequence Number: 1
• Product Code: NYU
• 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,Followup
• Report Date: 05/17/2017

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: 8888123405P
• Device Catalogue Number: 8888123405P
• Device Lot Number: 1507600083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided; 06/20/2017
• Supplement Dates FDA Received: 06/20/2017; 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1