MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; NEEDLE

Catalog Number PAIN0790A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that during an epidural steroid injection, the needle separated from its hub.A portion of the needle was exposed and the physician was able to manually remove it from the patient.There was no injury or need for further medical intervention as a result of this incident.The procedure continued without further incident.No sample was returned for evaluation.A root cause has not been determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

It was reported that during a procedure, the needle separated from its hub.

• Type of Device: NEEDLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5569779
• MDR Text Key: 42423964
• Report Number: 1417592-2016-00036
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAIN0790A
• Device Lot Number: 15LD0306
• Was Device Available for Evaluation?: No
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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): Other
• Patient Age: 69 YR