Catalog Number 383033 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that a crack was found in the bd intima-ii¿ closed iv catheter system, causing leakage to occur at the connection site during use.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the patient was admitted to the hospital due to burns, and was given anti-inflammatory drug infusion according to the doctor's advice.Before the injection, the patient was punctured with an indwelling needle.When checking the airtightness of the indwelling needle, a crack was found at the transparent tee, and there was leakage., abandon and replace the indwelling needle with a new one, successfully puncture the patient, report to the head nurse and make a record.The event did not harm the patient.
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Manufacturer Narrative
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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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H6: investigation summary: a device history review was conducted for lot number 2172312.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that a crack was found in the bd intima-ii¿ closed iv catheter system, causing leakage to occur at the connection site during use.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022, the patient was admitted to the hospital due to burns, and was given anti-inflammatory drug infusion according to the doctor's advice.Before the injection, the patient was punctured with an indwelling needle.When checking the airtightness of the indwelling needle, a crack was found at the transparent tee, and there was leakage.Abandon and replace the indwelling needle with a new one, successfully puncture the patient, report to the head nurse and make a record.The event did not harm the patient.
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Search Alerts/Recalls
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