MAUDE Adverse Event Report: BECTON DICKINSON SPINAL SET 25GA 3-1/2IN; NEEDLE, SPINAL, SHORT TERM

Catalog Number 405084

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

The needle was inserted into the intervertebral space for anesthesia sub-aracnoida the moment of the needle extraction there was disconnected connector from the needle, so the needle remained inserted in the column the needle was extracted with klemmer because the tail protruded a few millimeters from the skin.Involved patient.Incident that occurred on (b)(6) 2023.Has the device been used? yes.Consequence: specific intervention.Sample available.

Event Description

The needle was inserted into the intervertebral space for anesthesia sub-aracnoida the moment of the needle extraction there was disconnected connector from the needle, so the needle remained inserted in the column the needle was extracted with klemmer because the tail protruded a few millimeters from the skin.Involved patient: incident that occurred on (b)(6) 2023.Has the device been used? yes.Consequence: specific intervention.Sample available.

Manufacturer Narrative

Correction on imdrf code: b15 - analysis of data provided by user/third party.

• Brand Name: SPINAL SET 25GA 3-1/2IN
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18400458
• MDR Text Key: 331722634
• Report Number: 3003152976-2023-00554
• Device Sequence Number: 1
• Product Code: MIA
• UDI-Device Identifier: 00382904050849
• UDI-Public: (01)00382904050849
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405084
• Device Lot Number: 2210027
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1