Model Number 382523 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2021 |
Event Type
malfunction
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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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Event Description
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It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".
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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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Event Description
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It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".
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Event Description
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It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while introducing it into the patient's vein.The following information was provided by the initial reporter: "i talked to the nurse inserting the iv and she said: the catheter with needle did not look defective in any way out of the package.She entered the vein easily, and then started threading the catheter off of the needle.It would not thread and the needle was actually pushing itself back out of the patient.So she removed it, and the needle was coming out near the hub instead of at the tip ¿ where it should be.".
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Manufacturer Narrative
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The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 12/9/2021.Investigation: the device displayed evidence of media found on it which therefore is unlikely that the spear through originated during the manufacturing process as the device would have been received with the needle piercing through the catheter tubing making a venipuncture attempt unlikely.A needle spear through may occur in the clinician setting during tip adhesion break or during venipuncture if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.Based on the evidence, the spear through most likely originated during the venipuncture.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Search Alerts/Recalls
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