MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline Industries, Inc.; DBD-TUBING CHANGE KIT

Model Number LC310A

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Viral Infection (2248)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Emails received 8/11/2021 and 8/17/2021 by facility representative (t.R.), multicare health system, which contained additional information in regards to the reported incidents.Information in the email provided by (b)(6)., bsn, multicare health system.K.H.Reports, "(b)(6) ; (b)(6) ; (b)(6) (these are the dates of the positive blood cultures)." reporter states, "implementation of usage of the kits began on (b)(6).On 4/30/2021, a patient developed an infection that originates from or is related to a central venous catheter (clabsi).An investigation was performed, and it was discovered that a tubing unrelated to the kit was leaking and could have been the cause of the infection.Two more clabsis occurred after that." reporter states, "three clabsis occurred during the time we were using these new tubing change kits.Antibiotics (reporter declines to identify name of antibiotics) were needed and some babies became very ill (reporter declined to specifically identify which of the three reported patients became critical).Two of the infants are close to full term so may be able to be discharged home soon.The other infant is still critical preterm infant requiring respiratory support that is not unusual for his gestational age." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Samples have been received and evaluation has been completed (see report below).Due to the reported incident, medical intervention and in an abundance of caution, a med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.Evaluation summary: 08/19/2021 07:29:30 cst (bgomes) sample evaluation: "a sample was received for our investigation.One kit was received open for review.Visual inspection revealed there were multiple tubing sets with needleless adapters.It was also found to be missing tubing set 506724 set ext 60 pur-smallbore ns.There were 2 sets of 506723 set ext 60 smallbore w/microc and 1 of 506722 nicu quad line ns.All 3 tubing sets were inspection under a high magnification camera and no holes or openings were found.Functional testing revealed no issues.No loose connections of the tubing to the adapters were found.The clip on the tubing was used to close off the tubing.A syringe was then attached to the tubing and the plunger was pulled back.Resistance was felt when pulling back the plunger and when release the plunger was pulled back.The syringe was then removed and filled with water.The syringe was reattached to the tubing and the plunger was pressed in an attempt to push the water into the tubing.The water could not be pushed into the tubing with the clip engaged.No openings or leaks could be found with the received samples.".

Event Description

It was reported, "three central line-associated bloodstream infection (clabsis) have occurred in the neonatal intensive care unit (nicu) since the start of the tubing kit rollout on (b)(6) 2021." later email confirmed positive blood culture dates as, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.

• Brand Name: Medline Industries, Inc.
• Type of Device: DBD-TUBING CHANGE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12342440
• MDR Text Key: 267449916
• Report Number: 1417592-2021-00153
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10193489455564
• UDI-Public: 10193489455564
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LC310A
• Device Catalogue Number: LC310A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 9 DA