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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793009
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 06/06/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an ongoing dialysis treatment, the device had a leak between the tubing and the hub on the arterial line.It was indicated that there was a torn slip noted near the connector side (hub).It was also stated that about 150 to 200mls of patient's blood was lost as they were unable to return the blood in the dialysis filter set.A blood transfusion was required.The patient did not manifest any symptoms of hypotension but the patient was supported on vasopressors prior to the incident.The catheter was inserted.The blood flow rate was 150 ml/min and the dialysis was started.The treatment was not completed.The catheter was removed and a new one was inserted to continue the therapy.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an ongoing dialysis treatment, the device had a leak between the tubing and the hub on the arterial line.It was indicated that there was a torn slip noted near the connector side (hub).It was also stated that about 150 to 200 milliliters of patient's blood was lost as they were unable to return the blood in the dialysis filter set.A blood transfusion was required.The patient did not manifest any symptoms of hypotension but the patient was supported on vasopressors prior to the incident.The catheter was inserted.Chlorhexidine 2% was used as the cleansing agent and the patient was not on any ointment.It was also stated that it is not a practice to move the clamp if the treatment is completed.The blood flow rate was 150 ml/min and the dialysis was started.The hemoglobin levels of the patient pre treatment was 8.5 g/dl and post treatment was 9.1g/dl.The treatment was not completed.The catheter was removed and a new one was inserted on the same date to continue the therapy.The death is attributed to the patient's condition - acute myocardial infarction, and not related to the issue with the device.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.This defect has been confirmed.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time.100% devices are inspected for leaks or cuts.The most probable root cause can be considered as misuse.This defect was more likely caused during use due to sharp objects or rough edges.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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 st.
mansfield, MA 02048
2034925563
MDR Report Key7704214
MDR Text Key114500392
Report Number3009211636-2018-00236
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier20884521004808
UDI-Public20884521004808
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2022
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1711300140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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