MAUDE Adverse Event Report: MYCO MEDICAL SUPPLIES, INC MCKESSON BRANDS; NEEDLE EPIDURAL 18X3.5 TUOHY

Catalog Number 3076V2

Device Problem Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

The customer reported that multiple spinal needles received in a box had a curve to them.At least 4 in the box.Customer has noticed an increase in epidural hematomas and wondering if the needles may be the cause for the increase.No information was received regarding any serious injury as a result of this report.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE EPIDURAL 18X3.5 TUOHY
• Manufacturer (Section D): MYCO MEDICAL SUPPLIES, INC; 158 toverview court; cary NC 27513
• MDR Report Key: 12529310
• MDR Text Key: 274069625
• Report Number: 1451040-2021-00018
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 3076V2
• Device Lot Number: 2003562
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2021
• Distributor Facility Aware Date: 09/01/2021
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other