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

Model Number 8888145016

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted: the image depicts the top of the blue luer adapter looking down.The threads are mangled and the adapter has a crack.Without the physical device functional evaluation is precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, on preparation for dialysis, a crack/split was noted on the blue luer adapter, thus affecting normal use.There was no leak, no cleaning agent was used, tego was not utilized, no instrument was used to tighten or loosen the device.There was no blood loss and no transfusion was required.No other products was utilized with the device.The catheter was repaired and the adapter was replaced to resolve the issue.Iodine was the cleaning agent used.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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 9835789
• MDR Text Key: 194764813
• Report Number: 3009211636-2020-00069
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013176
• UDI-Public: 20884521013176
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 1729100103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1