Model Number 2434-0007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set screw cap fell off into the nurse's hand when disconnecting the tubing from the patient.The following information was provided by the initial reporter: "a green curos cap was attached to the end of the tpn tubing upon disconnecting this tubing from the patient.Upon doing so, the screw cap that the curos cap screws in to fell off into the rns hand.New tpn tubing had to be opened and hung with the bag of tpn.No patient harm.".
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Manufacturer Narrative
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Investigation summary: a sample was received and investigated with the customer's complaint of separation.The separation was not immediately noticed until the manufacturer's design document was analyzed and the missing piece (luer lock).The set was then inspected visually under microscope to determine that the failure was due to excess mechanical stress and that the solvent had been properly applied during production.It appears that the end of set broke off cleanly where it was adhered to the male luer end.A device history record review could not be performed because a lot number was not provided by the customer.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set screw cap fell off into the nurse's hand when disconnecting the tubing from the patient.The following information was provided by the initial reporter: "a green curos cap was attached to the end of the tpn tubing upon disconnecting this tubing from the patient.Upon doing so, the screw cap that the curos cap screws in to fell off into the rns hand.New tpn tubing had to be opened and hung with the bag of tpn.No patient harm.".
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Search Alerts/Recalls
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