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

Catalog Number	4290
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was too loose on the safety system, which meant that air enters the syringe when it is drawn up and that fluid leaks next to the needle when injecting.The needle spontaneously comes loose from the safety system during the puncture.Adverse patient effects are unknown.It was reported that no further information is available.
Additional Manufacturer Narrative
Other text: 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
Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.No product sample has been returned.The customer provided two photos, one identifying the lot number and the second showing the product configuration.Visual inspection of the pictures did not reveal any defects or anomalies.Without a product sample the reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.It is possible that the issues observed by the customer may have occurred if the mating luers of the components were not seated as instructed within the instruction for use (ifu).A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17856422
• Report Number: 3012307300-2023-09476
• Device Sequence Number: 19696248
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: 20351688046823
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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 Catalogue Number: 4290
• Device Lot Number: 4249493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown