MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 20GA 3-1/2IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405182

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: there was no sample available but 3 photos were provided to bd for evaluation.Evaluation of the 3 photos resulted in the confirmation of the reported issue.Bd cannot confirm the reported issue was part of the manufacturing process without a sample to evaluate.A review of the device history record was performed and no quality issues were found during production.Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: a root cause could not be determined.Rationale: per (b)(4) the reported issue does not represent a single significant incident that would trigger a capa.Per complaint history check is the 1st complaint reported for the defect/condition on lot number provided.

Event Description

It was reported that needle spinal s/su 20ga 3-1/2in quincke was discolored.The following information was provided by the initial reporter: it was reported that the needles appear to be contaminated.From investigation "in the first and second photo is observed a stain in the top web.".

• Brand Name: NEEDLE SPINAL S/SU 20GA 3-1/2IN QUINCKE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 12168203
• MDR Text Key: 264510025
• Report Number: 2618282-2021-00044
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051822
• UDI-Public: 00382904051822
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405182
• Device Lot Number: 0093620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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