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

Catalog Number	4237
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: 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 or Problem Description
It was reported that the needle got stuck in the patient's leg.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Received for investigation: a non-shipping carton containing four original presentation boxes of product 4237 lot number 4388949.The actual sample used from the time of the complaint was not returned.Visual inspection of the provided components did not reveal any defects or anomalies.All needles were assembled to the needle-pro device within the package and remained assembled as they were removed from the packaging.To determine if the needle would become detached from the needle-pro device 80 samples (taken from all four boxes) were divided into two sets.Sample size was according to c=0 (critical).The first set was tested following ifu (10011078-002, section 6.2) by attaching the needle-pro to the syringe and needle to the needle-pro, using a push and clockwise twist.Using a medicine vial (0.9% sodium chloride for injection) to simulate actual use, the needle cannula was inserted through the septum of the vial.Three ml of sodium chloride (nacl) was drawn into the syringe, and then expelled back into the bottle.The needle was extracted from the vial while observing for signs of detachment of the needle from the needle-pro device and/or syringe.This was repeated 5 times.Results: all results were acceptable.The sample functioned as intended and remained assembled.To test the above assembly for liquid leakage between mating luers, the syringes was filled with a colored fluid.The returned samples functioned as intended.No leakage or disconnect was observed between the mating luers (needle-pro/needle assembly and/or syringe).The second set was tested by the same methods as above, but without seating and tightening the components together as instructed by the ifu.All results were acceptable with no leakage or detachment noted.Based on the results of this investigation, this complaint could not be confirmed with the samples provided.Therefore, no further action will be taken 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 described within the ifu.However, the details of the complaint do not allow us to confidently determine if the instructions were followed prior to and during the procedure.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be 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: 19593683
• Report Number: 1217052-2024-00043
• Device Sequence Number: 4160350
• Product Code: FMI
• UDI-Device Identifier: 20351688048834
• UDI-Public: (01)20351688048834(17)280405(10)4388949
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Catalogue Number: 4237
• Device Lot Number: 4388949
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: Male