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

Catalog Number 4290

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 324769840
• Report Number: 3012307300-2023-09476
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: 20351688046823
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K923127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4290
• Device Lot Number: 4249493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1