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

Catalog Number	SSN100235
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "needle popped off syringe and poked employee.Another incident - needle popped off and needle stuck in baby.".
Additional Manufacturer Narrative
The customer reported that the needle was securely attached to the syringe; in the first incident, after giving a shot, the needle detached from the syringe and was left inside the baby, and in the second incident during the capping of the safety needle after giving an injection, the needle flew off the syringe.After the first incident, the needle was removed from the baby; in the second incident, the m.A.Washed site and went to work comp clinic to be evaluated, and both individuals are fine.The investigation included review of the lot/serial number and recent complaint trends for the past 3 months; sample(s) were not received for investigation and no pictures were available.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, the cause was documented as sample required to determine cause, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.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: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884574
• Report Number: 1417592-2026-50036
• Device Sequence Number: 18626722
• Product Code: FMF
• UDI-Device Identifier: 30193489031953
• UDI-Public: 30193489031953
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/23/2026

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)89721090001
• 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: 10/12/2023
• Initial Report FDA Received Date: 09/24/2026
• 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