MAUDE Adverse Event Report: NEW GERTIE MARX NEEDLE, 25G X 215MM; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 19268

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 09/17/2019

Event Type  malfunction  

Event Description

Apparent manufacturing defect with special order needles used for transforaminal lps to administer nusinersen (spinraza).This approach lps enters fully at the side of the body (near the mid-axillary line, just above the iliac crest), not the midline of the back.The needle enters the spine through a nerve root foramen.The first procedure is done in interventional radiology (ir) using dyna ct to show that there is a safe path into the spine that avoids bowel, kidney and lung.If the first dose goes well, a subsequent dosing in dsu pa/pb using operating room c-arm fluoroscopy.The needles for these lumbar punctures (lp) need to be very long, i.E.At least 8 ¿ 10 inches (20 ¿ 25 cm).Special ordered needles called "new gertie marx needles", 25 gauge noncutting, in lengths ranging up to 21.5 cm (8.5 inch).These are made by imd inc.Yesterday, when performing a transforaminal lp in dsu, placed one of these needles into the subarachnoid space, tried to gently aspirate, and found inability to get a seal.Tried tuberculin syringes and t-connectors, as well as several different luer syringes.Opened a second needle from the same batch, and the same problem occurred.It looks as if the hubs are not made properly and they are too soft, and even with very gentle application of a syringe, they shred and leak.We ended up performing the transforaminal lp using a 22 g 20 cm chiba needle, obtained from ir.Using the chiba needle, the lp was straightforward, cerebrospinal fluid was sampled, the patient received dose of nusinersen, did fine.

• Brand Name: NEW GERTIE MARX NEEDLE, 25G X 215MM
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• MDR Report Key: 9150893
• MDR Text Key: 161168779
• Report Number: 9150893
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

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 Lot Number: 19268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 84