MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO 3ML NEEDLE-PRO W/ SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4234
Medical Device Problem Code	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 leaking occurred through the plunger.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Received for investigation: one box containing fifty unopened packages of product from the reported lot number.The product used at the time of the complaint was not returned.Visual inspection of the samples provided did not reveal any defects or anomalies.All returned samples were found to be assembled within the packages prior to opening.To evaluate the complaint, the returned samples were tested for leakage past the plunger according.Leakage past the plunger was observed among thirteen products, thus complaint confirmation.The syringe is a supplied item which is purchased as an assembled product (syringe barrel, plunger, and plunger tip rubber).Inadequate manufacturing from the supplier is the root cause of this issue.The complaint information has been shared with the manufacturer.Icu medical 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.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: JELCO 3ML NEEDLE-PRO 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19973859
• Report Number: 1217052-2024-00076
• Device Sequence Number: 7087150
• Product Code: FMI
• UDI-Device Identifier: 20351688048803
• UDI-Public: (01)20351688048803(17)260126(10)4096060
• 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): 12/10/2024

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 4234
• Device Lot Number: 4096060
• 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: 11/21/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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