MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO EDGE NEEDLE; 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	09/01/2024
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 medication was seeping around the plunger (like it is not a tight seal).There was unknown patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Received for investigation: one box containing 38 unopened packages of product with the reported lot number.Also included were 18ea of the same product from a different lot number, however there was no associated complaint assigned to these samples.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 needles and needle-pro devices were found to be assembled within the packages prior to opening.The returned samples were tested for leakage past the plunger.Results: no leakage past the plunger was observed.The complaint was not confirmed or duplicated.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 most likely the root cause of this issue, however it cannot be stated with confidence.Icu medical no longer purchases this component.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 EDGE NEEDLE
• 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: 20493838
• Report Number: 1217052-2024-00139
• Device Sequence Number: 17024074
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)241120(10)3916180
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: 11/20/2024
• Device Catalogue Number: 432215
• Device Lot Number: 3916180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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