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

Model Number	NC5011B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three unused devices that were returned were evaluated.The samples were inspected under magnification.The were no signs of luer connection warpage or deformities.No foreign material or glue was present.When the collar was pushed down to the collar stop, there was material interference that made the collar stick when trying to slide the collar upwards.
Event or Problem Description
A complaint was received, part number nc5011b- lot # 19292, due to the sliding collar not being able to move.When it does move it is sticky as if there is dried glue obstructing the movement of the spinning collar.The connection to the catheter hub could not be made securely enough to withstand a ct procedure.

• 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: 10550748
• Report Number: 1000304305-2020-00004
• Device Sequence Number: 16912613
• Product Code: FPA
• UDI-Device Identifier: 15019517133196
• UDI-Public: 15019517133196
• 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: NC5011B
• Device Lot Number: 19292
• 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