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

Model Number 8888145014

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, it was stated that obvious cracked was noted in the first thread of the red (arterial) end joint.They said that there was nothing unusual observed on the device prior to use and flushing was done.The catheter was not repaired, leak at the luer adapter was noted, cracked was observed in the red (arterial) joint and it was the only damage noted on the device.Iodophor was used to clean the device, tego was not utilized, they said that they tighten the adapters by hand and there was no other products being utilized with the device, there was no patient symptoms or complications related to the event.There was eventual blood loss of 5ml, but blood transfusion and medical intervention was not required.Product has been replaced and the treatment was completed.There was no patient injury.

Manufacturer Narrative

Additional information: a4(weight in lbs.), b5, d10, g4, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the cannula of the catheter was cut very close to the hub connection.This disengaged end was not received.The red and blue luer adapters were received with the red sealing cap attached to the blue adapter.The extension tubes, clamps, and bifurcate hub appeared intact.The adapter was visualized via microscopic evaluation and no cracks were present.Functional testing would normally include leak testing however, the tube was cut too close to the adapter precluding this type of testing.It was reported that the luer adapter was leaking, cracked, or broken.The reported issue could not be confirmed.The most likely root 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.

Event Description

According to the reporter, during use, it was stated that obvious crack was noted in the first thread of the red (arterial) end joint/luer adapter.They said that there was nothing unusual observed on the device prior to use and flushing was done.Catheter was not repaired, leak at the luer adapter was noted, cracked was observed in the red (arterial) joint and it was the only damage noted on the device.Iodophor was used to clean the device, tego was not utilized, they said that they tighten the adapters by hand and there was no other products being utilized with the device, there was no patient symptoms or complications related to the event.There was eventual blood loss of 5ml, but blood transfusion and medical intervention was not required.Product has been replaced and the treatment was completed.There was no reported patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10137807
• MDR Text Key: 194645794
• Report Number: 3009211636-2020-00112
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013145
• UDI-Public: 20884521013145
• Combination Product (y/n): N
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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 Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 1922500107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 49