MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL NEEDLE 27GA 3.50 IN; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 405259

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: multiple photos were provided to our quality team for investigation.Through visual inspection, the label is observed to be missing from the case.A device history review was performed for reported lot 2003002, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Products undergo visual and functional inspections according to procedure.All results were reviewed for lot 2003002 and no issues were identified.While we could not identify a direct issue, it was determined the root cause of this incident is due to operator error as the label is manually placed onto the case.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the label is missing from packaging with a bd spinal needle 27ga 3.50 in.The following information was provided by the initial reporter: no catalog.No production date.No date expiry.No lot.

• Brand Name: BD SPINAL NEEDLE 27GA 3.50 IN
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12202290
• MDR Text Key: 263399965
• Report Number: 3003152976-2021-00409
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K091758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405259
• Device Lot Number: 2003002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1