Catalog Number 305209 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Pr 9341129: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f27 ¿ no patient involvement.Device problem code: a2101 - device markings / labelling problem.
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Event Description
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Rcc received a complaint via email.Email(s) attached.The expiry date is not mentioned on the bag with syringes or on the small bag with caps lot#: 0148085.
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Manufacturer Narrative
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(b)(4) - follow up mdr for correction.Following submission of the initial mdr, it was determined that this complaint is a duplicate of (b)(4) and was not needed.No further action will be taken.
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Event Description
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This complaint is a duplicate of (b)(4).
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Search Alerts/Recalls
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