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

Model Number 8888145044P

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: diane matheus ; 15 hampshire street; mansfield, MA 02048 ; 5085421480
• MDR Report Key: 6852050
• MDR Text Key: 85372663
• Report Number: 3009211636-2017-05290
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158092
• UDI-Public: 10884521158092
• 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
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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