Catalog Number 2970.150.20 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that the green lid and spring damaged.This occurred during priming.There was no patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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One device was received.Visual inspection confirmed that the blade fixing ball and spring have fallen off.The cause was unknown.The device history record (dhr) is at the supplier and not readily available for review.The product was returned to the customer as unrepairable because no replacement parts were available.
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Search Alerts/Recalls
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