Model Number 382523 |
Device Problem
Retraction Problem (1536)
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Patient Problems
Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
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Event Date 10/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.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 insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to occ health, they told her what to do with the patient, and sers was completed.
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one needle in the barrel of an insyte autoguard unit.A gross visual inspection shows a unit that has been used and the needle retracted in the barrel.The barrel has some stress marks and has a slight bent near the rear end.The safety button has a crack, and it is fully engaged.In attempt to reproduce the issue of retraction failure, the needle was reengaged by pushing it out.The safety button was pushed, and the needle retracted but stopped at the bent on the barrel.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Without the complete device, a full investigation could not be performed.This type of defect may occur during manufacturing due to a damaged barrel from machine misalignment.However, since the device has been handled, therefore this defect could have occurred in the used environment due to improper handling or storage condition.A device history review (dhr) cannot be performed as no lot number was provided by the complainant.Without the other part of the device to identify additional damages, the root cause cannot be determined with certainty.H3 other text : see h10.
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Event Description
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It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the needle would not retract and a dirty needle stick occurred.The following information was provided by the initial reporter: nurse got stuck with a needle due to a malfunctioning iv device, the needle did not retract she went to (b)(6) health, they told her what to do with the patient, and sers was completed.
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Search Alerts/Recalls
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