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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device leaked medication before it was given to the patient.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.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
Investigation summary: received for investigation eleven presentation boxes of hypodermic needle 4234 lot # 4107235.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.To evaluate the returned products for leakage they were tested accordingly to the combo leak test.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.Leakage past the plunger was observed among twenty-one products, thus complaint confirmation.Root cause was not determined.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 previously been shared with the manufacturer and a snn was issued to them.Icu 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.

• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19248135
• Report Number: 1217052-2024-00012
• Device Sequence Number: 6438391
• Product Code: FMI
• UDI-Device Identifier: 20351688048803
• UDI-Public: (01)20351688048803(17)260126(10)4107235
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 4107235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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