MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE)

Model Number	NEPI-NLD 15597C-20
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Above patient was scheduled to undergo a cesarean section.Prior to spinal injection for spinal block, a particulate, which appeared to be plastic, was noted in the barrel of the syringe.The syringe was not used on the patient.

• Brand Name: PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE)
• Common Device Name: PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE)
• Manufacturer (Section D): SMITHS MEDICAL; keene NH 03431
• MDR Report Key: 7645559
• Report Number: MW5078114
• Device Sequence Number: 176451
• Product Code: MIA
• UDI-Device Identifier: 15019517115710
• UDI-Public: (01)15019517115710
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: No Information
• Device Expiration Date: 03/01/2020
• Device Model Number: NEPI-NLD 15597C-20
• Device Lot Number: 3637355
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 93