MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ QUINCKE SPINAL NEEDLE, BLACK HUB; ANESTHESIA SPINAL NEEDLE

Catalog Number	405181
Health Effect - Clinical Codes	Abscess (1690); Pain (1994); Fungal Infection (2419)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: bd was unable to perform a thorough investigation as no sample or lot number were provided.No samples or lot number was provided.Dhr review and sterility record check cannot not be performed without a lot number.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that a patient contracted a fungal infection after receiving an epidural injection using a bd¿ quincke spinal needle, black hub.The patient had an epidural injection on (b)(6) 2017 and went to the emergency room (er) with low back pain on (b)(6) 2017.An mri confirmed an epidural abscess.The patient had surgery to remove and culture the abscess and underwent rehab.The patient is reportedly doing well at this time.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE, BLACK HUB
• Common Device Name: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7137159
• Report Number: 2618282-2017-00041
• Device Sequence Number: 1310578
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 405181
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention