MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SPINAL NEEDLE 20GA 1.50 IN

Catalog Number 405251

Device Problem Break (1069)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the spinal needle 20ga 1.50 in broke off into the patient while performing a medical procedure, exposing the staff and patient to spinal fluid, and requiring the removal of the broken needle and changing to a new one.The following information was provided by the initial reporter: "needle broke off whilst in patient.Medical team doing procedure on patient when the needle broke in the patient." exposure: spinal fluid.Medical intervention: needle needed to be changed.

Manufacturer Narrative

Investigation: no photos or physical samples that display the reported condition were provided for investigation.A device history review was performed for reported lot 1803012, no deviations or non-conformance's related to this issue were identified during the manufacturing process.Two retained samples of the same lot were used for evaluation.The product was inspected using a microscope, no defects or markings were observed on the needle that could cause a breakage.Product is routinely inspected according to procedure to avoid any defects.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that the spinal needle 20ga 1.50 in broke off into the patient while performing a medical procedure, exposing the staff and patient to spinal fluid, and requiring the removal of the broken needle and changing to a new one.The following information was provided by the initial reporter: "needle broke off whilst in patient.Medical team doing procedure on patient when the needle broke in the patient." exposure: spinal fluid medical intervention: needle needed to be changed.

• Brand Name: SPINAL NEEDLE 20GA 1.50 IN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8536470
• MDR Text Key: 142737380
• Report Number: 3003152976-2019-00280
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 405251
• Device Lot Number: 1803012
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention