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

Model Number	8888145049C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to covidien on 06/27/2017 that a customer had an issue with a dialysis catheter.The customer reported that there was a leak at the junction of the extension tube and bifurcate.The device was explanted and replaced.There were no patient symptoms or complications associated with this event.
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 sample consisted of one palindrome catheter.The catheter came inside a plastic bag and it presented signs of use.In addition, the sample was cut 3.5 cm below the hub.Visual inspection was performed and the catheter did not present other visual issues.Functional testing was required.The returned sample was submitted to an underwater test.Bubbles were detected coming out below the hub from the lumen of the arterial extension.The lumen which corresponds to the venous extension had no bubbles detected.An ishikawa diagram was used to determine the potential causes for this event.Multiple components are used in the manufacture of this product.Components properties are tested by the suppliers and there are controls in place in the manufacturing site to prevent non-conforming material to be used.During the manufacturing process, catheters are submitted to a 100% pressure testing.Through visual evaluation it was observed that the catheter was cut 3.5 cm below the hub.Due to the appearance of the catheter received it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use and use of cleaning agents, resulting in a catheter leakage.Additionally the catheter was in use for an undetermined time without issues, which implies that the defect occurred after customer manipulation.The instructions for use (ifu) warn not to use the catheter if the package has been previously opened or is damaged.It warns not to use acetone on any part of the catheter.The ifu also says to exercise caution when using sharp instruments near the catheter; the catheter tubing can tear when subjected to nicks, excessive force, or rough edges and to inspect the catheter frequently for nicks, scrapes, cuts, etc.Which could impair its performance.Moreover, the issue found caused a leak which would have been identified during assembly operations, since manufacturing performs 100% pressure testing during production.This reported condition has been confirmed.Based on the available information, it can be concluded that product was manufactured according to specifications.The most probable root cause can be considered as damage during use caused due to an inappropriate manipulation by the user.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, such as personnel training, incoming quality acceptance testing for (b)(4), 100% in process visual inspection and visual acceptance sampling, 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 reported there was a leak at the junction of the extension tube and bifurcate.The device was explanted and replaced.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Submit date: 7/24/2017.A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported failure.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 actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since a sample, picture or video were not received for testing, and therefore the reported issue was not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) 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 reported there was a leak at the junction of the extension tube and bifurcate.The device was explanted and replaced.There were no patient symptoms or complications associated with this event.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• MDR Report Key: 6673714
• Report Number: 3009211636-2017-05213
• Device Sequence Number: 46108
• Product Code: MSD
• UDI-Device Identifier: 10884521083059
• UDI-Public: 10884521083059
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 8888145049C
• Device Catalogue Number: 8888145049C
• Device Lot Number: 128716X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 09/12/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/24/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1