MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN SPINAL NEEDLE TRAY; SPINAL ANESTHESIA KIT

Lot Number	0061850656
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Our seasoned anesthesia team reports 3 recent failed spinal anesthesia encounters when using braun's bupivacaine 0.75% (ndc 0264-9379-88, one such lot is 20328a that exp 3/2025) taken out of a braun pre-packaged pencan (r) spinal needle tray labeled as gtin (b)(4), exp 4-30-2024, lot 0061850656.They report hospira's 0.75% (ndc 0409-3613-01) vial has no efficacy issues.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15959001
• Report Number: MW5113722
• Device Sequence Number: 5550122
• Product Code: OFU
• UDI-Device Identifier: 04046964180590
• UDI-Public: 04046964180590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/08/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2024
• Device Lot Number: 0061850656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVACAINE 0.75% SPINAL 0.75% UNK - UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female