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administration.Patient did not receive the full dose.The device was handled by a healthcare professional.The device was withdrawn from use.There was patient involvement.The incident has been reported to the regulatory agency.Nca reference number (b)(4) and mhra reference (b)(4).Associated needle complaint documented on (b)(4).
Additional Manufacturer Narrative
H3: five presentation boxes of products: 4291, lot: 4320592 were received for evaluation.The product used at the time of the complaint was not returned for investigation.Visual inspection of the returned hypodermic needle-pros did not reveal any defects or anomalies.All returned needles and needle-pro devices were found to be assembled within the packages prior to opening.To determine if the needle would become detached from the needle-pro device, 80 samples (c=0, critical sampling) were tested.The hypodermic assemblies were attached to a 3ml test syringe from lab stock according to sections 6.2 & 6.3 of the ifu (as10011150-002), by firmly seating the needle-pro to syringe and needle to the needle-pro, using a push and a clockwise twist.Using a medicine vial (0.9% sodium chloride for injection) to simulate actual use the needle cannula was inserted within the injection site of the vial and then extracted while observing for signs of detachment of the needle from the needle-pro device and/or test syringe.This was repeated 5 times for each sample.As a result, all the samples remained assembled throughout testing.No detachment of the needle from the needle-pro device was observed.Test 2: to test the returned samples for leakage between mating luers, the samples were assembled to a fluid filled, 3ml, luer-lock syringe (from stock), the assemblies were tested according to qtm\022-00-00, combo leak test.Results: the returned samples functioned as intended.No leakage was observed between the mating luers.The complaint could not be confirmed.It is possible that the issues observed by the customer may have occurred if the mating luers of the components were not seated as described within the ifu.Complaint information will continue to be monitored for any new information or adverse trends, and further actions will be taken accordingly.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• 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: 22524967
• Report Number: 3012307300-2025-08441
• Device Sequence Number: 15441664
• Product Code: FMI
• UDI-Device Identifier: 20351688046816
• UDI-Public: (01)20351688046816(17)290816(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): 11/26/2025

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: 10/16/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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