Catalog Number 515052 |
Device Problems
Leak/Splash (1354); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.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.
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Event Description
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It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".
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Manufacturer Narrative
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Medical device expiration date: unknown.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.
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Event Description
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It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".
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Manufacturer Narrative
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H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process, including testing to verify all critical dimensions are within specification such as the luer threading.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.
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Event Description
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It was reported bd phaseal optima injector (n35-o) had a leakage issue.The following information was provided by the initial reporter: "the nurse looked and saw that the female connector that should have been attached to the line with the taxol infusion wasn't attached and the medication was dripping onto the patient instead of infusing into her port.".
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Search Alerts/Recalls
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