Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888135191
Device Problem Material Puncture/Hole (1504)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 01/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during postoperative dialysis, it was found that there was blood leakage in the middle segment of the transparent silicone tube.It was stated that the catheter was not repaired, no cleaning agent was used, no dico additive was used, there was no luer adapter issue.Patient outcome reported was alive but with injury as catheter implantation required reoperation.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo noted: the catheter is being held at the blue lumen.The catheter is clean, no abnormalities observed.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 postoperative dialysis, it was found that there was a small hole that caused blood leakage in the middle segment of the transparent silicone tube to the venous (blue) extension line.It was stated that the catheter was flushed prior to use and there was leakage.There was no other no other products being utilized with the device.It was stated that the catheter was not repaired, no cleaning agent was used, no dico additive was used, there was no luer adapter issue.There was no reported blood loss and no medical intervention was required.There was no patient injury reported.
 
Event Description
According to the reporter, during postoperative dialysis, it was found that there was a small hole that caused blood leakage in the middle segment of the transparent silicone tube to the venous (blue) extension line.It was stated that the catheter was flushed prior to use and there was leakage.There was no other no other products being utilized with the device.It was stated that the catheter was not repaired, no cleaning agent was used, no dico additive was used, there was no luer adapter issue.There was no reported blood loss and no medical intervention was required.There was no patient injury reported.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo noted: the catheter is being held at the blue lumen.The catheter is clean, no abnormalities observed.Post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: the red port, blue port, clamps, bifurcate and cannula appeared intact.A functional evaluation found that the distal end of the cannula was clamped and a water bath test was performed, air bubbles were detected in the middle of the extension tube on the blue port side.A small hole was observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the hole in the extension tube may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8350206
MDR Text Key136490432
Report Number3009211636-2019-00036
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 company representative,distri
Type of Report Initial,Followup,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/17/2023
Device Model Number8888135191
Device Catalogue Number8888135191
Device Lot Number1807300111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Initial Date Manufacturer Received 01/22/2019
Initial Date FDA Received02/19/2019
Supplement Dates Manufacturer Received02/12/2019
06/13/2019
Supplement Dates FDA Received03/07/2019
06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-