Catalog Number 328421 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that while using the bd ultra-fine¿ insulin syringe it leaked.The following was received by the initial reporter: verbatim: on (b)(6) 2023, the patient went to hospital due to diabetes, and his blood sugar was 27.8 mml/l after measurement.Ordinary insulin 5u subcutaneous injection was given to the patient based on the doctor's advice before lunch.When drawing out the liquid medicine, the liquid medicine leaked from the connection between the rubber stopper and the body of the needle tube.Immediately replacing it with a new disposable sterile insulin syringe and explaining to the patient and the family members.The incident did not cause harm to the patient.
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Event Description
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It ws reported that while using the bd ultra-fine¿ insulin syringe it leaked.The following was received by the initial reporter: verbatim: on june 23rd, 2023, the patient went to hospital due to diabetes, and his blood sugar was 27.8 mml/l after measurement.Ordinary insulin 5u subcutaneous injection was given to the patient based on the doctor's advice before lunch.When drawing out the liquid medicine, the liquid medicine leaked from the connection between the rubber stopper and the body of the needle tube.Immediately replacing it with a new disposable sterile insulin syringe and explaining to the patient and the family members.The incident did not cause harm to the patient.
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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Search Alerts/Recalls
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