MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL¿ NEEDLE; SPINAL NEEDLE

Catalog Number 405259

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

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 during use of the bd spinal¿ needle ¿the guide is broken and does not fit with the syringe, so the medication is filtered, additionally, the needle does not have a lid.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: no samples or pictures have been received for investigation by our quality team.An evaluation of two retained samples was performed.Upon visual inspection, no defects were noted.Both retained samples have the shield.A leakage test was performed according to internal procedure with no leakage found.During the packing the packaging process inspections are performed to avoid faulty parts.A device history record review found no non-conformances associated with this issue during production of this batch.A root cause cannot be determined based on the evaluation of the two retained samples and device history review.Based on the low severity and frequency of the defect and acceptable results for retained samples and manufacturing process, it was determined that no capa is required.

• Brand Name: BD SPINAL¿ NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7280301
• MDR Text Key: 100556715
• Report Number: 3003152976-2018-00057
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 405259
• Device Lot Number: 1607002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other