• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CENTRAL VENOUS CATHETER TRAY

  • 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
 

MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CENTRAL VENOUS CATHETER TRAY Back to Search Results
Model Number DYNDC2002A
Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924)
Event Date 08/18/2023
Event Type  malfunction  
Event Description
We have been experiencing issues with the central line caps for the past 6 months.There has been no patient harm in any of the reported events.No product available for return.Event #1: nurse (rn) drawing labs and noticed cap cracked.No product available for return.Event #2: notified, and line change completed.Lot number is 22lbb740.Cap from kit #dyndc2002a no product available for return.Event #3:transduced port (red port) or peripherally inserted central catheter (picc) had cracked cap and infusions were leaking on bed.Rn noticed the crack during her assessment, unsure of how long they were leaking.Upon assessment, the cap appeared cracked and fluid had filled the entire cap.The cap change kit that the broken cap was taken from was lot #22lbb740 cap from kit #dyndc2002a no product available for return.Event #4: newly placed picc in interventional radiology (ir), both caps cracked and fluid/blood filled the cap between plunger and outside plastic no product available for return.Event #5: during morning labs, the blue cap on my patients internal jugular (ij) was found to be broken.Saq nurse was immediately notified.Resulted in 2ml of blood unable to be returned to patient.Hubs cleaned per policy + cap removed, and lines directly attached without a cap event #6: while bathing patient noticed the umbilical artery catheter (uac) was backing up with blood.When i flushed it, fluid started to leak out of the cap.Had our safety nurse come confirm that the cap was cracked and a sterile line change was performed.After completion we noticed that the picc line white cap was starting to back up and do the same thing.Upon inspection, it was noted that the cap had also cracked and a sterile line change was completed.Cap from kit #dyndc2002a no product available for return.Event #7: microclave cap on red lumen of left femoral picc line noted to be cracked with blood and condensation backing up into the cap.Per charting cap changed previous day utilizing cap change kit (medline, #dyndc2002a, lot #23cbq551,).At the time when the cap was noted to be cracked central venous line (cvl) fluids with a transducer without a med line attached on the red lumen of the picc line.Cap/tubing for the affected lumen was changed.No product available for return.Event #8: new caps placed on patient's picc line.Red port was the line used to transduce a central venous pressure (cvp).Upon placing cap there were no issues, as soon as the cvp fluids were started to transduce the pump was reading occluded.Upon attempts to flush from the transducer and the closest stopcock - saq rn was unable to flush any fluid through.Saq then disconnected the line from the cap and was able to flush through the cap with no issues.Same error read on pump channel and upon closer look at the cap, there was fluid accumulating inside the cap.Kit that the cracked cap had come from was the medline cap change kit, #dyndc2002a lot number 23cbq551 no product available for return.Event #9: upon shift change and completing bedside report, rn found red port cap of picc to be cracked with blood inside.On previous night shift cap/tubing was completed and caps were placed on both ports from kit #dyndc2002a with lot # 23cbq551.Labs were drawn via red lumen of picc line and it was noted to have blood the next morning.An additional cap/tubing (dyndc2002a with lot # 23cbq551) was competed on the red port of the picc after finding the blood in the cap.This rn arrived and assessed pt with off going rn after additional labs were redrawn prior to visualizing pt.Blood was noted in the cap, again, of the red port of the picc line.Labs were able to be drawn/obtained, but waste was unable to be given back via trifurcate through the stop cock/extension back to the picc line.Another cap/tubing was completed, using a kit (#dyndc2002a with lot # 23cbq551) with an individual cap placed on the stop cock).Cap/tubing collected and saved.Event #10: cap cracked and leaking blood.Event #11: patient had cap and tubing performed on the left arm picc on the day before.Upon running a medication through the white port of the picc, the newly placed cap appeared to be filled with liquid and looked like there was a small leak.The rn checked all connections to ensure that the line was connected and the medication finished running and had no other leaks or issues.Upon drawing labs, the cap appeared to have a bubble of fluid when drawing back blood and when flushed the cap filled with blood.New cap and tubing kit obtained and new cap placed on the white port.The broken cap came from a cap and tubing kit with #dyndc2002a lot # 22lbb740.Item was removed and placed in a biohazard bag in d3 cns's box.Product was saved.Event #12: rn drawing labs from stopcock via trifurcate method (via red port of picc) and when flushing line, cap at proximal side of tubing (attached to the fem line catheter), had blood fill up and around plunger within the cap.This cap had tubing attached to it, which consisted of transducer tubing set up to primary tubing spiked into cvl fluid.Tubing and cap were changed, collected and saved with safelink on sticky note (placed in team leads box) and new microclave cap lot number placed on catheter (from kit) and microclave cap on stopcock (individual) was entered into microclave audit sheet.Line had blood return with new cap placement.Also to note, the fem line cap/tubing was changed the previous shift and microclave cap was from kit.First cap/tubing changed cap from kit #dyndc2002a lot # 23cbq551 second cap/tubing changed the next day cap on red port at catheter from kit #dyndc2002a lot # 23cbq551 and cap placed on stopcock of the transducer no product available for return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDLINE INDUSTRIES, INC.
Type of Device
CENTRAL VENOUS CATHETER TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key17860404
MDR Text Key324801017
Report Number17860404
Device Sequence Number1
Product Code OFF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/29/2023,08/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDYNDC2002A
Device Catalogue NumberDYNDC2002A
Device Lot Number22LBB740
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2023
Event Location Hospital
Date Report to Manufacturer10/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30 DA
Patient SexMale
-
-