MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO EDGE 3ML NEEDLE 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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medication leaked out and did not get to the patient.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Reason device not evaluated by mfg: other; device was 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: 22 samples were received for investigation.The lot numbers and quantities are as follows: fourteen unopened samples of lot # 4136814, three sealed packages of lot # 4141025 and five samples in a bag with the tyvek material identifying the product as lot # 4141025.Samples of the lot number referenced by the customer complaint form were not returned.Visual inspection of the provided product found that one in the opened bag had a broken plunger.All remaining retuned product (21) did not have any defects or noted anomalies.During the functional testing of the samples, leakage was observed among nine of the 21 samples tested.The syringe used in the manufacturing of these finished goods is a supplied item.It is purchased as an assembled product (syringe barrel, plunger and plunger tip rubber).Based on the results of the provided returned samples the complaint was confirmed, and inadequate manufacturing from the supplier is the root cause of this issue.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.Dhr review found no discrepancies or anomalies relevant to the complaint.

• Brand Name: JELCO EDGE 3ML NEEDLE W/ SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene MN 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20640916
• Report Number: 1217052-2024-00179
• Device Sequence Number: 15319463
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)260416(10)4141023
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 4141023
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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