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Model Number 16827 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/12/2022 |
Event Type
Injury
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Event Description
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Office manager of physician's office contacted technical solutions to report a patient's adverse reactions after a refill procedure.During the call, technical solutions determined that during the refill, only 9ml of the 20ml was able to be pulled back when the volume check was performed.Based on this information, this issue is believed to a pocket fill rather than a pump malfunction.Narcan was administered to the patient and they were taken to the hospital.Office manager reported that the patient is doing fine now.
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Manufacturer Narrative
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Pending follow up information regarding patient symptoms.A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Internal complaint number: (b)(4).
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Manufacturer Narrative
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Although several attempts were made to confirm details regarding the patient's symptoms, no additional information was able to retrieved from the physician's office.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
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Search Alerts/Recalls
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