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.

Event Description

Please verify where the break occurred, did a piece of the spinal needle break off in the patient? did the needle disconnect from the hub? is a photo available? was any medical intervention required? it is confirmed that the needle has disconnected from the hub and has therefore remained within the patient's spine.It was necessary for the anesthesiologist with klemmer to extract the needle which fortunately protruded a few mm.As already specified in the incident report, the sample is available and is obviously contaminated with blood as shown in the attached images.Tomorrow, we will give you feedback in order to prepare for possible withdrawal.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, the image shows the stylet on one side, the cannula and the cannula hub separated from the cannula.Therefore, the incident is confirmed.However, physical samples are required to further analyze and evaluate the product to determine a root cause.A device history review was performed for lot 2210027 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Nine retained samples from the same lot were evaluated, no defects were observed on the needle or any other components of the device.Product undergoes a series of testing and inspections throughout the manufacturing process the ensure the quality and functionality of the device, including verification the needle is free from damage or defects and all critical dimensions are within specification.All inspections for lot 2210027 were completed according to procedure, no annotations were noted related to the reported incident.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.

Event Description

No additional information.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, the image shows the stylet on one side, the cannula, and the cannula hub separated from the cannula.Therefore, the incident is confirmed.Additionally, physical sample was received and decontaminated for evaluation.The physical sample was evaluated using magnification, no damage or defects were observed.A device history review was performed for lot 2210027 ,no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Nine retained samples from the same lot were evaluated, no defects were observed on the needle or any other components of the device.Product undergoes a series of testing and inspections throughout the manufacturing process the ensure the quality and functionality of the device, including verification the needle is free from damage or defects and all critical dimensions are within specification.All inspections for lot 2210027 were completed according to procedure, no annotations were noted related to the reported incident.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.

• 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