MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO NEEDLE-PRO STANDALONE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4292
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the needle popped off during the injection and leaked.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: received for investigation one presentation box containing a total of 100 unopened original packages for product: 4292, lot: 4454357.The actual used device(s) were not returned for evaluation.Visual inspection of the returned samples did not reveal any defects or anomalies.All needles (ne484) were assembled to the needle-pro devices (mp836) within the packages and remained connected as they were removed from the packaging.To determine if the needles would become detached from the needle-pro devices or if the needle-pro detached from a stock syringe, 80 samples were tested by simulating actual use.Note: sample size was determined according to: c=0, critical.The samples were assembled by firmly seating the needle to the needle-pro and the needle-pro to the syringe, using a push and a slight twist.Using a medication vial (0.9% sodium chloride for injection) to simulate actual use of drawing medication from a vial and/or injecting the patient, the needle cannula was inserted within the injection site of the vial and then extracted from the vial while observing for signs of detachment.This was repeated five times per sample.All results were acceptable.All samples functioned as intended and remained assembled.To determine if leakage would occur between the mating luers of the needle and the needle-pro device, the samples were tested for liquid leakage.No leakage was observed on any sample.The issue observed by the customer could not be reproduced with the returned samples.Therefore, 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 (instructions for use).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: JELCO NEEDLE-PRO STANDALONE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene IN 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19973855
• Report Number: 1217052-2024-00077
• Device Sequence Number: 20604737
• Product Code: FMI
• UDI-Device Identifier: 20351688046854
• UDI-Public: (01)20351688046854(17)281218(10)4454357
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 4292
• Device Lot Number: 4454357
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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