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

Model Number	8888145044P
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
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 during hemodialysis they found a hole in the catheter where the venous luer connector joins the silicone extension.The catheter was replaced and there was 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.Three photos were provided by the customer.Visual evaluation of the photos was performed.A hole was observed in one of the extension tubes (blue adapter).One used catheter was received for decontamination.However, the actual sample involved in the reported incident had been discarded by mistake before the sample could be evaluated.The photos attached in the complaint by the decontamination laboratory showed one palindrome catheter with signs of use.Additionally, according to the event description and the photo received by the customer, this complaint was confirmed although the sample was not tested.An ishikawa diagram was used to determine the potential causes for this event.The reported condition has been confirmed.Based on pictures provided by 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 damage during use caus ed due to the use of strong cleaning agents, a sharp object, excessive force during use or repeated clamping.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.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.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 6852050
• Report Number: 3009211636-2017-05290
• Device Sequence Number: 16159435
• Product Code: NYU
• UDI-Device Identifier: 10884521158092
• UDI-Public: 10884521158092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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: 04/11/2018
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1512400103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1