MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 23GX1

Catalog Number	SSN100235
Medical Device Problem Codes	Protective Measures Problem (3015); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there have been 4 reports of needle sticks due to the needle not being sheathed when coming out of the package.The account is also stating the item is too flimsy and does not meet the standards of a safety locking mechanism.
Additional Manufacturer Narrative
The account reported needle sticks due to the needle not being sheathed when coming out of the package and stated the item is too flimsy and does not meet the standards of a safety locking mechanism; the facility also reported a staff member experienced a needle stick with a clean needle that was not used on a patient.At this time, a sample(s) was not received for investigation; investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 3 months, and objectionable trends were not seen for this issue.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.Sample required to determine cause; no medical intervention, serious injury, or follow-up care has been reported, and the division has been informed and will continue to monitor trends.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: NEEDLE,HYPODERM,SAFETY, 23GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50735358
• Report Number: 1417592-2026-37125
• Device Sequence Number: 21474999
• Product Code: FMF
• UDI-Device Identifier: 30193489031953
• UDI-Public: 30193489031953
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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
• Device Catalogue Number: SSN100235
• Device Lot Number: (10)89721070001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown