Model Number 309582 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd luer-lok¿ syringe with attached needle 25 g there were connection issues and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i mentioned to her that the bd 3ml 25g 1 1/2 syringe/needle that sometimes came with the pediatric ancillary kit actually did not have the needle part firmly affixed to the syringe.The saline solution can leak out from the side of the syringe where the needle and the syringe meet.I thought that was the way it comes in and that we just have to be more careful to make sure the needle is affixed to the syringe firmly before using it.The affected vaccines were reported as waste and were never used for immunization.Nobody received an incorrect dose as a result.The nurse told me this is actually considered a defect and i should report it.The lot numbers that we have are 0351034, 0351032, and 0351028.The total quantity is about 50 and they are already set aside in a bag and marked "do not use'.
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Manufacturer Narrative
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H.6.Investigation summary: 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.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.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.H3 other text : see h10.
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Event Description
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It was reported while using bd luer-lok¿ syringe with attached needle 25 g there were connection issues and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i mentioned to her that the bd 3ml 25g 1 1/2 syringe/needle that sometimes came with the pediatric ancillary kit actually did not have the needle part firmly affixed to the syringe.The saline solution can leak out from the side of the syringe where the needle and the syringe meet.I thought that was the way it comes in and that we just have to be more careful to make sure the needle is affixed to the syringe firmly before using it.The affected vaccines were reported as waste and were never used for immunization.Nobody received an incorrect dose as a result.The nurse told me this is actually considered a defect and i should report it.The lot numbers that we have are 0351034, 0351032, and 0351028.The total quantity is about 50 and they are already set aside in a bag and marked "do not use'.
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Search Alerts/Recalls
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