MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO HYPODERMIC NEEDLE EDGE W/SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	432215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe was leaking around the plunger.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: device not returned to manufacturer.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.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: 79 unopened samples were received for investigation.Samples were visually and functionally tested and leakage past the plunger was observed with 43 of the provided products.The syringe is a supplied item which is purchased as an assembled product.Inadequate manufacturing from the supplier was found to be the root cause of the issue.The complaint information has previously been shared with the manufacturer and a snn was issued to them.Icu has not purchased this assembly since 2022.At this time, no further actions will be taken.Complaint information will continue to be monitored for any new information and further actions taken accordingly.Dhr review found no discrepancies or anomalies relevant to the complaint.

• Brand Name: JELCO HYPODERMIC NEEDLE EDGE W/SYRINGE
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20818866
• Report Number: 1217052-2024-00211
• Device Sequence Number: 18353595
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)260416(10)4141025
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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 Expiration Date: 04/16/2026
• Device Catalogue Number: 432215
• Device Lot Number: 4141025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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