MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPO NEDL-PRO; NEEDLE-PRO STANDALONE

Catalog Number	4291
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Event or Problem Description
It was stated that the needle would not securely fit on the syringe.It was disconnected during drug administration.The needle was left in patient.The device was handled by a healthcare professional.The device was withdrawn from use.There was patient involvement.The incident has been reported to the regulatory agency.Nca reference number 2025/006/020/501/005 and mhra reference 35959506-aicxml.Associated needle complaint documented on cn-399210.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The reported that complaint of leakage was not observed between the mating luers.No detachment was observed.The complaint could not be confirmed.The product could not reproduce with the returned.Therefore, the complaint could not be confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: HYPO NEDL-PRO
• Common Device Name: NEEDLE-PRO STANDALONE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22525249
• Report Number: 3012307300-2025-08442
• Device Sequence Number: 8078574
• Product Code: FMI
• UDI-Device Identifier: 20351688046816
• UDI-Public: (01)20351688046816(17)270816(10))4320592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Catalogue Number: 4291
• Device Lot Number: 4320592
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown