MAUDE Adverse Event Report: BECTON DICKINSON SPINAL NEEDLE 27GA 3.50 IN; NEEDLE, SPINAL, SHORT TERM

Catalog Number 405259

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Csf leak when connecting a syringe.

Manufacturer Narrative

(b)(4) initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a050401 - fluid/blood leak.Patient problem code: f24 - insufficient information.

Event Description

Csf leak when connecting a syringe.

Manufacturer Narrative

Pr 9201341 follow up mdr for device evaluation: no photos or physical samples that display the reported condition were provided to our quality team for investigation.A device history review was performed for lot 2302024, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or defects were observed on or near the luer connection.Additional evaluations verified the products met required specifications, the needle was connected to a mating luer without issue and no leakages occurred.Product is visually and functionally tested throughout manufacturing according to procedure, verifying all critical dimensions are within specification.Testing results for lot 2302024 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: SPINAL NEEDLE 27GA 3.50 IN
• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18215517
• MDR Text Key: 329105544
• Report Number: 3003152976-2023-00516
• Device Sequence Number: 1
• Product Code: MIA
• UDI-Device Identifier: 00382904052591
• UDI-Public: (01)00382904052591
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K091758
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405259
• Device Lot Number: 2302024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1