MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY,22GX1.5

Catalog Number	SSN100227Z
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cap falls off while they are attaching the needle to the syringe.We have also heard the safety is difficult to use and does not always snap on securely.
Additional Manufacturer Narrative
The customer reported multiple occasions where staff experienced the cap falling off the needle while opening the packaging or while securing the needle to the syringe; not all experiences resulted in a needle stick, and staff expressed difficulty using the safety and the safety not locking in place as it should.The needle stick occurred prior to patient use; no serious injury, medical intervention, follow-up care, post-exposure tasks, or impact to the patient/provider was reported.Medline received 1 box of hypoderm safety needles; 20 were randomly selected for testing, all devices were removed safely without issue, device safety caps were removed and safety snaps were secured, and all devices worked as intended.The complaint was not confirmed, and the cause was documented as unconfirmed defect - not confirmed with received sample; investigation included review of recent complaint trends, no further action was taken because objectionable trends were not seen for this issue, and 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,22GX1.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50808012
• Report Number: 1417592-2026-43999
• Device Sequence Number: 15614407
• Product Code: FMI
• UDI-Device Identifier: 20193489031949
• UDI-Public: 20193489031949
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/17/2026

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: SSN100227Z
• Device Lot Number: 8972209001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2023
• 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: 08/01/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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