MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL POLYETHYLENE LINED TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14248-28

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Heparin initiated with icu medical plum 360 pump with pe lined tubing.Rn returned to room 10-15 minutes after initiation and blood was backflowing from central line through a small hole/crack in the tubing.Medication and tubing removed and new line initiated.Tubing sequestered.Lot #9405818 implicated in 4 possible tubing defects at local facility and lot has been removed.Product complaint #: (b)(4).Polyethylene lined tubing, secure lock 107 inch, product 14248-28; lot either #13827210 or #9405818.Reference report #mw5153339, #mw5153341, #mw5153342.

• Brand Name: ICU MEDICAL POLYETHYLENE LINED TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 19002585
• MDR Text Key: 338954399
• Report Number: MW5153340
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 14248-28
• Device Lot Number: 9405818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN.
• Patient Outcome(s): Other