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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Received for investigation two sealed primary packages for product 432215 lot numbers 4141022 and 4141024.Visual inspection of the returned samples did not reveal any defects or anomalies.The customer stated that the second lot ending in 024 did not have the half ml graduation markings on the syringe.Both packages were opened and examined.Lot number 4144022 had graduation scale markings starting at 0.5 ml with half ml increments to a 3ml capacity.The second lot, 4141024, had graduation markings only with numbers noted at the 1, 2, and 3ml.Review of the dhr and wip records for both lots indicated that three types of syringes can be used in assembling this hypodermic assembly.In this instance, two different syringes were used during the manufacturing of each lot.The syringe barrels are supplied items and come pre-printed.The finished good product is a standard item (not custom) therefore, it is possible that varying syringe styles will be used.Complaint information will continue to be monitored for any new information or adverse trends 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.
Event or Problem Description
It was reported that lot number 4141022 for product number 432215 has half-ml increments marked on the syringe, but new lot number 4141024 for the same product number does not.The fault was discovered upon opening.There was no patient involvement and no patient injury.

• 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: 20023928
• Report Number: 1217052-2024-00080
• Device Sequence Number: 7364070
• Product Code: FMI
• UDI-Device Identifier: 00351688071029
• UDI-Public: (01)00351688071029(17)260416(10)4141024
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 04/16/2026
• Device Catalogue Number: 432215
• Device Lot Number: 4141024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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