MAUDE Adverse Event Report: NP MEDICAL 7"(18CM) STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CON

Model Number	NC5011R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were received to perform an autopsy.
Event or Problem Description
A complaint was received, part number nc5011r, where iv access was started and iv fluids would not flow to gravity.

• Brand Name: 7"(18CM) STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CON
• Common Device Name: EXTENSION SET
• Manufacturer (Section D): NP MEDICAL; 101 union street; clinton MA 01510
• MDR Report Key: 10550442
• Report Number: 1000304305-2020-00002
• Device Sequence Number: 11531643
• Product Code: FPA
• UDI-Device Identifier: 15019517133202
• UDI-Public: 15019517133202
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K092382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: NC5011R
• Device Lot Number: 18130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1