Model Number VASOSHIELD PRESSURE CONTROLLING SYRINGE |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(4).
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Event Description
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Related to (b)(4).Ssu (b)(6) reported customer complains that the shelf life of the delivery of 5 packs of cvh-5001 vasoshield pressure controlling syringe | is too short < 12 months.A maximum usage time of 13 weeks after delivery is too short.Devices were withdrawn from circulation at the end of the period of use - therefore no use on patients, no impairment and/or damage.
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Manufacturer Narrative
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It has been determined complaints (tw#: (b)(4)) do not meet the definition of a complaint per (b)(4).Customer did not accept the devices because the devices they received had a relatively shorter shelf life, the devices were not defective and no adverse event was reported.Therefore, the complaint will be cancelled.
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Event Description
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It has been determined complaints (tw#: (b)(4)) do not meet the definition of a complaint per (b)(4).Customer did not accept the devices because the devices they received had a relatively shorter shelf life, the devices were not defective and no adverse event was reported.Therefore, the complaint will be cancelled.
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Search Alerts/Recalls
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