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

Catalog Number 405181

Device Problem Product Quality Problem (1506)

Patient Problems Abscess (1690); Pain (1994); Fungal Infection (2419)

Event Date 08/24/2017

Event Type  Injury  

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 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
• Type of Device: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7137159
• MDR Text Key: 95451059
• Report Number: 2618282-2017-00041
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405181
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention