MAUDE Adverse Event Report: BD MEDICAL BD SPINAL NEEDLE QUINCKE TYPE POINT 22 GAUGE 3.50

Lot Number 5254988

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2016

Event Type  Injury  

Event Description

During a left shoulder arthrogram, the clinician was attempting to remove the needle used for contrast injection.At the end of the procedure, the needle tip broke off (2.5 cm piece).It had a 90 degree bend in it (as viewed on ct) and was retained in the subscapularis tendon in the patient's left shoulder.Patient required removal of the needle fragment under sedation using fluoroscopy.

• Brand Name: BD SPINAL NEEDLE QUINCKE TYPE POINT 22 GAUGE 3.50
• Type of Device: QUINCKE TYPE POINT 22 GAUGE 3.50
• Manufacturer (Section D): BD MEDICAL; franklin lakes NJ 07417
• MDR Report Key: 5802588
• MDR Text Key: 49966760
• Report Number: MW5063485
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Lot Number: 5254988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 68