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

Catalog Number 4290

Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: d4: udi section and g5: 510k are 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.

Event Description

It was reported that while in use with a patient, the needle was too loose on the safety system.This caused air to enter the syringe when it was pulled up.Fluid leaks when the needle is injected.Adverse effects have not been reported.

Manufacturer Narrative

Evaluation codes: updated.No product was 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 for difficulties with the hypodermic 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 instructions for use (ifu).It is suggested to use a twisting motion when attaching the syringe to the luer connection of the needle-pro device.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The issue will be monitored for threshold or escalation.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17761372
• MDR Text Key: 323909913
• Report Number: 3012307300-2023-08974
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 09/25/2023
• 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