MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/9 PCC

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number: (b)(4).Event occurred in (b)(6).The patient's father reported that the cannula from an infusion set stayed in his daughter's body and the infusion set was inserted about 3-4 weeks ago before this report.She indicated that the site looked infected and two weeks before this report, she was prescribed antibiotics by the doctor.But, the infection reappeared again, and the doctor performed surgery under local anesthetic.The area was cleaned, and a piece of plastic was removed from her body that was curled up in a ball.When the piece of plastic was removed it springed back straight and it was the cannula of the infusion set that was stuck inside the skin.The doctor gave her new antibiotics.The samples of discharge from the wound were sent to a lab.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/9 PCC
• MDR Report Key: 8324667
• Report Number: 3003442380-2019-00506
• Device Sequence Number: 19237345
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 02/10/2019
• Patient Sequence Number: 1