MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888223216
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer states after insertion of the catheter the nurses put on the dressing as normal.The second day, when the nurse opened the dressing to start the first dialysis treatment, the arterial/red extension was found to be broken at the clamp site.The catheter was replaced with no harm to the patient.
Additional 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.A video was provided by the customer.Visual evaluation was performed, and it revealed a clinician flushing the catheter with a syringe and substance leakage was observed from the arterial extension at the clamp site.One used catheter was received for analysis and investigation.Visual evaluation of the sample revealed signs of use and several cuts were observed on the tubing.The reported condition has been confirmed.Based on the video and sample provided by the customer, it can be concluded that the device functioned as intended for an undetermined amount of time.100% of the devices are inspected for leaks or cuts in the extensions per procedure.The most probable root cause can be considered as more likely damaged during use due to the use of strong cleaning agents, sharp object, excessive force during of use or repeated clamping or other similar damage.The evidence provided is enough to discard the manufacturing process as a potential cause.No trends or triggers have been found.Therefore, a corrective and preventive action is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Additional 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 physical sample involved in the reported incident was not returned for evaluation, however a video was provided by the customer.Visual evaluation of this video was performed and it revealed a catheter was inside the patient.The clinician flushed the catheter with a syringe and substance leakage was observed from the arterial extension at the clamp site.The exact origin of the leakage could not be determined with this video.As per the instructions for use (ifu), the customer has to perform a visual inspection before using the device.The ifu states not to clamp the dual lumen portion of the catheter; clamp only the extensions.When clamping, use only clamps supplied with the catheter.The ifu cautions that clamping the catheter extensions repeatedly in the same spot could weaken the tubing and to change the position of the clamp regularly to prolong the life of the tubing.The reported condition was not identified prior to insertion of the catheter.The reported condition has been confirmed.Based on the video provided by the customer it can be concluded that 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.The evidence provided is enough to discard the manufacturing process as a potential cause.No trends or triggers have been found.Therefore, a corrective and preventive action (capa) is not deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states after insertion of the catheter the nurses put on the dressing as normal.The second day, when the nurse opened the dressing to start the first dialysis treatment, the arterial/red extension was found to be broken at the clamp site.The catheter was replaced with no harm to the patient.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 6875302
• Report Number: 3009211636-2017-05301
• Device Sequence Number: 1404634
• Product Code: MPB
• UDI-Device Identifier: 10884521125926
• UDI-Public: 10884521125926
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: 8888223216
• Device Catalogue Number: 8888223216
• Device Lot Number: 1510300090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017; 01/02/2018
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/12/2017; 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR