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

Model Number	8888145048CP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on the day of catheter insertion, during dialysis, 15 minutes after the patient's cvc (central venous catheter) connected to the machine bloodline (competitor's brand) following the due procedures described in the protocol of dialysis cvc management, the patient's catheter was not disconnected but it was loosened just enough from the machine line to allow for a small amount of blood.The device was not broken, but the nurse stated that it did not have a secure tightening.There was no blood loss, if not in an insignificant amount, it only contaminated the connection.There was leak from blue (venous) luer adapter but no crack observed.The nurse noted that in performing the line connection maneuver to the cvc, the thread of both lumens (venous and arterial) remains stained with blood, with slight dripping on the gauze sterile that wraps around the ends of the cvc.They leave the connections on sight so that if there should be a blood loss or disconnection, there were ready to intervene.The treatment was proceeded and completed.The caps of the attachment and detachment kit (combi stopper) was utilized.It was also mentioned that the luer attack did not make a full turn prior to use.Flushing was done and the result was no problems noted.The catheter was not repaired.It was also stated that amuchina med 0.05% was used as the cleaning agent on the device and it was compressed for three to four minutes then it was disconnected to clean the part and they put a dry agarza with a plaster on top.They typically utilized sodium hypochlorite 0.05% to clean the adapters.The insertion site was cleaned with sodium hypochlorite 0.05% prior to product placement.No ointment used.They loosen or tighten the device by only hands.Blood transfusion was not required.No intervention/treatment required as a result of the event.There was no patient injury.
Event or Problem Description
According to the reporter, on the day of catheter insertion, during dialysis, 15 minutes after the patient's cvc (central venous catheter) connected to the machine with competitor's bloodline following the due procedures described in the protocol of dialysis cvc management, the patient's catheter was not disconnected but it was loosened just enough from the machine line to allow for a small amount of blood.The device was not broken, but the nurse stated that it did not have a secure tightening.There was no blood loss, if not in an insignificant amount, it only contaminated the connection.There was leak from blue (venous) luer adapter but no crack observed.The nurse noted that in performing the line connection maneuver to the cvc, the thread of both lumens (venous and arterial) remains stained with blood, with slight dripping on the gauze sterile that wraps around the ends of the cvc.They leave the connections on sight so that if there should be a blood loss or disconnection, there were ready to intervene.The treatment was proceeded and completed.The caps of the attachment and detachment kit (combi stopper) was utilized.It was also mentioned that the luer connec tion did not make a full turn prior to use.Flushing was done and the result was no problems noted.The catheter was not repaired.It was also stated that amuchina med 0.05% was used as the cleaning agent on the device and it was compressed for three to four minutes then it was disconnected to clean the part and they put a dry gauze with a plaster on top.They typically utilized sodium hypochlorite 0.05% to clean the adapters.The insertion site was cleaned with sodium hypochlorite 0.05% prior to product placement.No ointment used.They loosen or tighten the device by only hands.Blood transfusion was not required.No intervention/treatment required as a result of the event.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3 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: 12243552
• Report Number: 3009211636-2021-00183
• Device Sequence Number: 14547292
• Product Code: MSD
• UDI-Device Identifier: 10884521158146
• UDI-Public: 10884521158146
• 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): 12/21/2021

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: 07/07/2023
• Device Model Number: 8888145048CP
• Device Catalogue Number: 8888145048CP
• Device Lot Number: 2020400100
• 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: 12/06/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 12/21/2021
• 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
• Patient Sex: Unknown