MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NDL RF CRV SHRP 22GX10CMX10MM

Catalog Number	RFA221010CSL
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we got several of these needles like this that came in where it looks like the packaging got reversed and it was open on the other side so it wasn¿t sterile in the box.".
Additional Manufacturer Narrative
The customer reported several needles came in where it looked like the packaging got reversed and it was open on the other side, so it was not sterile in the box.A photo was received for the investigation, the customer provided photos of the outer packaging, finished good production records were reviewed, and the finished good pack build was reviewed.Based on the complaint details, photo evaluation, and investigation, the complaint is confirmed; review of the provided photos confirmed that the packaging of the product was not properly sealed.The root cause for the reported issue is determined to be employee error, as the pouch was incorrectly oriented during sealing, preventing proper formation of the required seal, and the division will monitor this issue for trending purposes.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: NDL RF CRV SHRP 22GX10CMX10MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abramms ; three lakes drive; medline industries, lp, IL 60093
• MDR Report Key: 50867092
• Report Number: 1417592-2026-48529
• Device Sequence Number: 10715964
• Product Code: GXI
• UDI-Device Identifier: 10195327381677
• UDI-Public: 10195327381677
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032196
• 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): 09/22/2026

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: RFA221010CSL
• Device Lot Number: 25EBD421
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2025
• 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: 11/04/2025
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown