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U.S. Department of Health and Human Services

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

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888135191
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, on (b)(6) 2020, the patient had a temporary hemodialysis catheter for emergency dialysis.On (b)(6) 2020, the patient underwent the third dialysis at the hemodialysis center.It was stated that the patient had a clear mind, and the answers were streamlined.He had no abnormal agitation, and was sleeping after getting on the device.At 14:48, the patient raised his leg, and scratched around the right groin while sleeping, and accidentally pulled out the temporary hemodialysis tube in the right groin.The machine alarmed, and the nurse stepped forward to check, and found that the arterial line was full of air bubbles, and immediately stopped the pump.It was said that they checked the catheter, found that the catheter had been pulled out, pressed immediately, checked that the catheter fixing wings and sutures were intact fixed on the patient's thigh, but the catheter had been pulled out.It was stated that they have reported to the doctor, and re-punctured the blood vessel to give blood back, and also assessed the patient's vital signs, which were stable.The blood pressure was 137/63mmhg, heart rate was 67 beats/min, breathing was 19 beats/min, but there was a blood loss of 20ml.It was noted that they communicated with the family members of patient.There was no reported patient injury.
 
Manufacturer Narrative
This report 3009211636-2020-00187 was sent in error as a duplicate for mfr report number: 3009211636-2020-00187, any additional information received in the future will be captured and submitted under the report number 3009211636-2020-00187.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.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key10592051
MDR Text Key208747893
Report Number3009211636-2020-00240
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521006447
UDI-Public10884521006447
Combination Product (y/n)N
PMA/PMN Number
K030209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 10/28/2020
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 Expiration Date10/29/2023
Device Model Number8888135191
Device Catalogue Number8888135191
Device Lot Number1831100158
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received09/28/2020
Supplement Dates Manufacturer Received10/09/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
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