MAUDE Adverse Event Report: NP MEDICAL, INC 7" STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CONNECTOR

Model Number	NC5011B
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three extension sets containing luer connectors have collars that are difficult to pull down and they get stuck.The returned samples 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, 7" (18 cm) standard bore extension set with bonded neusite¿ clear needleless connector (apv 0.65 ml) pressure rated to 325 psi, lot number 19286.The removable collar was difficult to pull down and gets stuck.

• Brand Name: 7" STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CONNECTOR
• Common Device Name: EXTENSION SET
• Manufacturer (Section D): NP MEDICAL, INC; 101 union street; clinton MA 01510
• MDR Report Key: 11586525
• Report Number: 1000304305-2021-00001
• Device Sequence Number: 19813332
• 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): 03/29/2021

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: 19286
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1