MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SPINAL NEEDLE

Catalog Number UNKNOWN

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Weakness (2145); Anxiety (2328); Injury (2348); Numbness (2415); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple follow-up attempts made to the facility to obtain samples and additional information regarding this event were unsuccessful.The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed.No specific conclusions could be drawn.While no specific conclusion can be drawn, incidents of this nature can generally occur when the needle is subjected to some type of trauma during use that stresses the device beyond its design capabilities.No adverse quality trends of this nature were identified during the complaint review process involving spinal needles.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the tip of a spinal needle was discovered in a patient today.It is currently planned to remove the needle fragment from the patient.The reporter indicated that the patient did have a procedure performed within the last several months.The reporter is unsure of which product was used for the patient in the previous procedure, but does know the facility uses b.Braun trays and needles.No additional information is available at this time.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Additional information was received on 30jul2018, it was stated that during a total knee replacement surgery, the doctor made several attempts to accomplish the spinal anesthesia.During one of the attempts the needle stuck in the ligamentum flavum and the m.D.Applied pressure which broke the needle or one of its component(s), parts, or accessories.A piece of the broken needle or one of its component(s), parts, or accessories remains in the plaintiff's back, extending into the spinal canal where the distal end of the spinal cord lives.The patient did not discover the alleged issue until (b)(6) 2016 when a mri of the patient's lower back was performed revealing an artifact consistent with a metallic foreign body.The patient claims that the product was defective and that he has suffered severe and permanent injuries including, but not limited to: severe back pain, weakness and numbness, loss of enjoyment of life, anxiety, and worry.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: SPINAL NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6099142
• MDR Text Key: 59778317
• Report Number: 2523676-2016-00713
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention