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

Catalog Number	4292
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there was an issue with the needle detaching from the safety housing and syringe when injecting.Specifically, when withdrawing the needle after injecting, the needle stays behind.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: three presentation boxes containing 294 unopened packages of product 4292 lot # 4331396 were received for evaluation.Also included among the returned samples were four non-icu medical hypodermic needles.The needle-pro sample or syringe used at the time of the complaint was not received for investigation.Visual inspection of the returned samples did not reveal any defects or anomalies.To determine if the needles would become detached from the needle-pro protection devices or if the products detached from the syringe, 80 samples of product (taken from all three boxes) were tested by simulating actual use.The hypodermics were assembled according to the ifu (instructions for use) by firmly seating the needle to the needle-pro and the needle-pro to a test syringe, using a push and slight twisting motion.A vial (containing 0.9% sodium chloride) was used to simulate actual use of drawing medication from a vial and/or injecting a patient.The cannula was inserted within the injection site of the vial and extracted while observing for signs of detachment.Results: all results were acceptable.All samples functioned as intended and remained assembled.The samples were then tested according to combo leak test.The samples met the requirements for the functional testing.Based on the findings, this complaint could not be confirmed with the provided hypodermic needles; therefore, no further actions will be taken at this time.It is possible that the issues observed by the customer may have occurred if the mating luers of the components were not seated as instructed 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: JELCO HYPODERMIC NEEDLE-PRO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20452631
• Report Number: 1217052-2024-00133
• Device Sequence Number: 20594171
• Product Code: FMI
• UDI-Device Identifier: 20351688046854
• UDI-Public: (01)20351688046854(17)271012(10)4331396
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 4331396
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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