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

Model Number 8888135241

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient was having dialysis treatment once a day for three hours.It was reported that the patient was agitated during dialysis and protective restraint was given to the patient limbs.At 1.5 hours of dialysis, the machine alarmed and found the catheter was detached.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph of a device.The photo depicts the catheter being used on a patient during a medical procedure.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 7919307
• MDR Text Key: 122167139
• Report Number: 3009211636-2018-00312
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• 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,Followup
• Report Date: 11/06/2018

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: 07/02/2022
• Device Model Number: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 1720700099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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
• Patient Age: 62 YR