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

Model Number	8888541019P
Medical Device Problem Codes	Misconnection (1399); Material Integrity Problem (2978)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 15 minutes into the dialysis session, after the patient's cvc (central venous catheter) was connected to the machine's lines and the procedure that was described in the protocol of cvc dialysis management was being followed, the patient's catheter (venous site) was disconnected from the machine line causing a 300 ml (milliliter) of blood loss.It was also stated that blood transfusion was performed, the treatment was continued and was completed.The patient continues to use the catheter which was not visually broken.The staff checks the catheter and the dormouse was tightened several times during dialysis to resolve the issue of the device.It was observed on the device that the fixing ring did not make a full turn, flushing was performed with normal result, the plugs of hemodialysis or locking caps were provided or utilized at the detachment, the nursing staff have increase the supervision as the intervention done, the adapters were tighten by hands and no ointment was used.There was a slight dripping on the sterile gauze that was wraps around the ends of the cvc.The catheter was not repaired, there was a leak at the luer adapter and the luer adapter was detached.It was also mentioned that amuchina med (sodium hypochlorite) 0.05% was used as the cleaning agent on the device and to clean the adapters.It was compress for three to four minutes then it was disconnected to clean the part and the put a dry agarza (sterile fabric gauze) with a plaster on top.It was observed that the thread of both lumens (venous and arterial) remains stained with blood and the patient was stated to have a hemorrhagic anemia.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but photos were available for evaluation.Visual inspection noted the first image depicts the red and blue luer adapters, extension tubes and clamps.The second image depicts a different and angle view of the red and blue luer adapters, extension tubes and clamps.The third image depicts a close up view of the red and blue luer adapters, extension tubes and clamps.The fourth image depicts the blue luer lock adapter.The fifth image depicts a top view of the luer lock adapter.The sixth image depicts a different angle looking down at the luer lock adapter.The seventh image depicts a close up looking down at the luer lock adapter.The eighth image depicts a close up of the luer lock adapter.The ninth image depicts a close up of the luer lock adapter.The tenth image depicts a side view of the luer lock adapter.No cracks were visible in any of the received photographs.It was reported that the luer adapter was leaking, cracked or broken and there was an issue with the connector.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12239010
• Report Number: 3009211636-2021-00178
• Device Sequence Number: 4157849
• Product Code: MSD
• UDI-Device Identifier: 10884521158498
• UDI-Public: 10884521158498
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 8888541019P
• Device Catalogue Number: 8888541019P
• Device Lot Number: 2009300115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown