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

Lot Number	UNKNOWN
Medical Device Problem Code	Material Twisted/Bent (2981)
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 china.On (b)(6) 2024, it was reported by the patient that he found bent cannula after removal from the insertion site.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was 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: 19369127
• Report Number: 3003442380-2024-02748
• Device Sequence Number: 15320100
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• Combination Product (Y/N): N
• PMA/510(K) Number: K070430
• 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): 05/22/2024

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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown