Catalog Number UNKNOWN |
Device Problems
Burst Container or Vessel (1074); Crack (1135)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that during use, an unspecified bd syringe and needle cracked and exploded the medication (xolair) while being injected.This occurred on two separate occasions.There was no report of injury or medical intervention needed.
|
|
Manufacturer Narrative
|
Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Investigation conclusion: no root cause can be determined as no samples were received.
|
|
Search Alerts/Recalls
|