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U.S. Department of Health and Human Services

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

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MICROBORE ULTRA EXT SET 36" SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 5441433
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Spontaneous call. Patients mother reports that they received another shipment of tubing containing tubing from lot 5441433 and the tubing has a portion of tubing that is solid which prevents priming and infusion. Product fault did not occur while in use. Product fault did not cause injury. Product expiration date unknown. Product being replaced. Patient had altemate tubing from different lot to use. Infusion is life sustaining. No other information available. Reported to (b)(6) by pt/caregiver.
 
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Brand NameMICROBORE ULTRA EXT SET 36"
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key14359596
MDR Text Key291510634
Report NumberMW5109636
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number5441433
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

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