MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT HUONS MEDLINE KIT W/ BUPIVACAINE; EPIDURAL ANESTHESIA KIT

Model Number	DYNJRA9028
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medline spinal block 25g wht 5s "kit" - bu item#: (b)(6) that contains: bupivacaine hydrochloride in 8.25% dextrose injection, usp spinal 0.75% ndc: 73293-0002-02.The administering surgeon reports that the bupivacaine was not effective during spinal block.I attempted to report to medline, who would not accept the report.I did reach out to the manufacturer of the bupivacaine huons but have not yet received a reply.

• Brand Name: HUONS MEDLINE KIT W/ BUPIVACAINE
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT
• MDR Report Key: 21834542
• Report Number: MW5169000
• Device Sequence Number: 21175699
• Product Code: OGE
• UDI-Device Identifier: 10884389285701
• UDI-Public: (01)10884389285701
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: DYNJRA9028
• Device Catalogue Number: DYNJRA9028
• Device Lot Number: 24LBP560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown