MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SPINAL BLOCK TRAY

Catalog Number	DYNJRA2056
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "an anesthesiologist was stuck by a needle that somehow was not secure in packaging.".
Additional Manufacturer Narrative
This is a combination product according to the facility, an anesthesia provider was stuck with needle through packaging while pulling the kit out of a drawer for use; the package was unopened, the product remained unused, and a band-aid was applied.Medline received and evaluated a sample; upon removing the trays from the pack, the 24g spinal needle pencan was in two pieces, the spinal needle was separated from the introducer needle, the spinal needle had a cover over the tip, the tip on the introducer needle was exposed, visible holes were present in the csr wrap and plastic pouch, and the remaining components were secured as they should be; finished good production records and pack build history were reviewed with no issues identified that might have had an impact or would contribute.The reported problem was confirmed by sample evaluation, and based on the complaint details, it is likely the pencan spinal needle and introducer needle became detached due to human error during the manual pack assembly process.The quality team will monitor this issue for trending purposes, production and qc managers have been notified, and feedback will be provided to the build team for awareness and to prevent recurrence in the future.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: DBD-SPINAL BLOCK TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771856
• Report Number: 1417592-2026-40353
• Device Sequence Number: 10614504
• Product Code: OFT
• UDI-Device Identifier: 40195327256327
• UDI-Public: 40195327256327
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 09/11/2026

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: DYNJRA2056
• Device Lot Number: 22LBK641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2023
• 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: 11/14/2023
• Initial Report FDA Received Date: 09/15/2026
• 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