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

Catalog Number	4288
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sprays meds out of needle".There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).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
H3 and h6.Evaluation codes: updated.Received for investigation a non-icu medical carboard box containing several bags of the device product with the reported lot number.The total amount of samples was 304, and all were returned, sealed in the original packaging.The actual product used at the time of complaint was not returned.To determine if the complaint could be replicated/duplicated, the samples were tested to simulate actual use.The needle cannula was inserted within the septum site of vial containing 0.9% sodium chloride.The needle was extracted from the vial while observing for signs of detachment of the needle from the needle-pro device and/or test syringe.This was repeated 5 times for each sample.All samples functioned as intended and remained assembled.A leak test was also performed, and the returned samples functioned as intended.All samples met the requirements for the tests conducted during this investigation.Based on the results of this evaluation, 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.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 HYPODERMIC NEEDLE-PRO NEEDLES
• 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: 19299249
• Report Number: 1217052-2024-00016
• Device Sequence Number: 14869266
• Product Code: FMI
• UDI-Device Identifier: 20351688046809
• UDI-Public: (01)20351688046809(17)280307(10)4384481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 4288
• Device Lot Number: 4384481
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: Unknown