Model Number 383532 |
Device Problems
Leak/Splash (1354); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced an incorrect colored device and leakage.The following information was provided by the initial reporter.The customer stated: the nurse write this: i need to apply blue pvk to a patient who needs an infusion.When i unpack the package on the blue pvk 22 g, the butterfly is blue, but the one where you rinse through with nacl is pink where it is normally blue? i make sure it's the right lumen on the needle and that's it.That's why i use the pvc.It works fine to install the pvc, which returns blood in the hose and i close at the clamping screw.When i have to rinse with saline i open the clamping screw and blood comes out where the pink piece should be stuck on the hose and when i try to rinse in, saline comes out of the pink piece but not into the hose.Therefore, the pvc is discontinued and a new one must be placed.
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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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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-22.H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one used unit.Upon inspection of the received unit, it was observed that the winged adapter and the y luer adapter were not the same gauge (as indicated by the different colors).It was also noted that extra space was present around the extension tubing and the inner wall of the y adapter.This was identified to be a result of the mismatched extension tubing and y adapter.The device was tested for leakage but no leakage was observed during the test.Although leakage was not observed, it could have been prevented due to the visible dried media inside the connection of the extension tubing and the y adapter being unable to be removed.Based on the observations, it is likely that leakage occurred during use.The defects of mixed product and leakage were confirmed and were determined to be related to the the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Event Description
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It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced an incorrect colored device and leakage.The following information was provided by the initial reporter.The customer stated: the nurse write this: i need to apply blue pvk to a patient who needs an infusion.When i unpack the package on the blue pvk 22 g, the butterfly is blue, but the one where you rinse through with nacl is pink where it is normally blue? i make sure it's the right lumen on the needle and that's it.That's why i use the pvc.It works fine to install the pvc, which returns blood in the hose and i close at the clamping screw.When i have to rinse with saline i open the clamping screw and blood comes out where the pink piece should be stuck on the hose and when i try to rinse in, saline comes out of the pink piece but not into the hose.Therefore, the pvc is discontinued and a new one must be placed.
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Search Alerts/Recalls
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