MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 110/6 PCC MECA

Lot Number	5211022
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the saudia arabia.On (b)(6) 2024, the patient's mother reported that her child's infusion set fell off due to tape not sticking on third day of insertion on the thigh as site location.No further information available.

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19357118
• Report Number: 3003442380-2024-02580
• Device Sequence Number: 19765038
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5211022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 05/21/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown