Catalog Number 381833 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 04/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd insyte¿ autoguard¿ iv catheter's safety mechanism failed to retract the needle and the nurse pricked their finger on it, requiring blood testing per protocol.The following information was provided by the initial reporter, translated from french: "during the insertion of a catheter, when removing the mandrel, one of our nurses tried to activate the catheter safety.However, the mechanism did not work, the chuck did not retract.The patient thought the procedure was over, moved and the nurse pricked her finger with the catheter.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 12-may2022 h6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one sealed 20g x 1.00in.Insyte autoguard unit from lot number 1222254.A gross visual inspection did not find any damage to the components.The unit was functionally tested for retraction.The unit successfully retracted.The reported issue could not be confirmed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in the report.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 that the bd insyte¿ autoguard¿ iv catheter's safety mechanism failed to retract the needle and the nurse pricked their finger on it, requiring blood testing per protocol.The following information was provided by the initial reporter, translated from french: "during the insertion of a catheter, when removing the mandrel, one of our nurses tried to activate the the catheter safety.However, the mechanism did not work, the chuck did not retract.The patient thought the procedure was over, moved and the nurse pricked her finger with the catheter.".
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Search Alerts/Recalls
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