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	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 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
B3: date of event is 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.
Additional Manufacturer Narrative
Investigation summary: one presentation box containing fifty unopened packages was received.The product used at the time of the complaint was not returned.Visual inspection of the provided samples 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 report stated that "syringes have been seeping around the plunger." to evaluate the customers complaint, the returned samples were tested.Prior to testing, the needle-pro was tightened to the syringe and needle to the pro, using a push and a slight twist and the caps manually removed.No leakage past the plunger was observed.Based on the results of the provided returned samples the complaint could not be confirmed.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 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 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: 20485877
• Report Number: 1217052-2024-00136
• Device Sequence Number: 11666371
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)290621(10)6028673
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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 Catalogue Number: 432215
• Device Lot Number: 6028673
• 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: 12/11/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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