Catalog Number 305269 |
Device Problems
Complete Blockage (1094); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using the bd integra¿ syringe with detachable needle the needle was clogged.The following was received by the initial reporter.The issue was solution did not inject and back fired externally.
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Manufacturer Narrative
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E.1.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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One sample was received by bd for evaluation.A quality engineer was able to review the sample of a 3ml syringe from lot #1278258 regarding item #(b)(4).The customer reported that "solution did not inject and back fired externally".The syringe was received in an opened package with all applicable product information on the top web.The syringe had the cannula and spring located inside the barrel with the stopper having been cut.It is possible that the syringe activated prematurely resulting in the cutting of the stopper and leakage of medication.A device history record review was completed for provided batch number 1278258.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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