MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PARACERVICAL/PUDENDAL BLK KIT

Catalog Number	DYNJRA9046
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue our provider is experiencing is that the needle will not progress all the way through the needle holder-it¿s stuck on something in the needle holder.".
Additional Manufacturer Narrative
The account reported that the needle will not progress all the way through the needle holder and that it is stuck on something in the needle holder; the customer also stated this was the 2nd experience with this issue and it is disconcerting to patients in the middle of an intimate, painful procedure.A sample consisting of twelve sealed kits was received, multiple kits were opened, the trumpet guides were inspected for defects and damage with none found, and the quincke spinal needle from the kit was used to test the trumpet guides.Upon placing the spinal needle into the trumpet guide, the needle advanced with no issue until it reached the exit tip, and multiple times the tip of the needle appeared to get stuck and not progress all the way through; the reported issue was confirmed.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process, and there has been no change to the reportability decision associated with this complaint.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: PARACERVICAL/PUDENDAL BLK KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948755
• Report Number: 1417592-2026-54658
• Device Sequence Number: 13167744
• Product Code: PVV
• UDI-Device Identifier: 40195327338610
• UDI-Public: 40195327338610
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• 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): 09/29/2026

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: DYNJRA9046
• Device Lot Number: 24DBE007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2025
• 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: 01/02/2025
• Initial Report FDA Received Date: 09/30/2026
• 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