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

Catalog Number	4234
Medical Device Problem Codes	Break (1069); 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 was defective due to leaking the medication before it could be delivered to the patient.There was patient involvement and no patient 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 a pallet of product, quantity received is unknown.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.A functional leak test was performed in which leakage past the plunger was observed among eleven 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 syringe manufacturer.Icu medical has not purchased this assembly since 2022.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 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: 19243236
• Report Number: 1217052-2024-00010
• Device Sequence Number: 6949613
• Product Code: FMI
• UDI-Device Identifier: 20351688048803
• UDI-Public: (01)20351688048803(17)260126(10)4096059
• 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): 07/08/2024

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: 4096059
• 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: 05/24/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/08/2024
• 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