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

Catalog Number	4236
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needles were leaking at the black hub.It did not help to tighten the needle or not it still leaks.There was patient involvement during the use of administering medication.No patient was harm.No medical intervention.
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Received for investigation, a clear bag and four presentation boxes containing total product qty 300.The actual 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.To evaluate the returned products for leakage they were tested.Results: leakage past the plunger was observed among twenty-six products, thus complaint confirmation.The syringe is a supplied item which is purchased as a complete assembled product (syringe barrel, plunger, and plunger tip rubber).The complaint information has been shared with the manufacturer of the syringe.At this time, no further action 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 HYPODERMIC 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19469307
• Report Number: 1217052-2024-00032
• Device Sequence Number: 3394503
• Product Code: FMI
• UDI-Device Identifier: 20351688048827
• UDI-Public: (01)20351688048827(17)260126(10)4107237
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 4236
• Device Lot Number: 4107237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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