MAUDE Adverse Event Report: MICROBORE ULTRA EXT SET 36 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MS406

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous call from patient's mom.When she received new tubing in order today, she described 9 sets as being "brown and almost dirty".All 9 sets were lot number 3742222 with expiration date july 1, 2023.The other tubing in the order had no issue and were different lots.Sending replacement tubing.Patient still has tubing and has not missed any therapy.Unknown if affected tubing is available for return.No further information.Reported to (b)(6) by pt/caregiver.

• Brand Name: MICROBORE ULTRA EXT SET 36 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 14488827
• MDR Text Key: 292972051
• Report Number: MW5109891
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/01/2023
• Device Model Number: MS406
• Device Catalogue Number: MS406
• Device Lot Number: 3742222
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male