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Model Number 11812558 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported that when he was placing a tb skin test and had engaged the safety which puts a cover over the top portion.Per customer, he went to put the cap on to discard and noticed that the safety disengaged.He was able to replicate it with two other needles, the safety disengages with light pressure.There was no harm reported.
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Manufacturer Narrative
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Since the reported lot number was incorrect, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.Section d4 (lot number): originally reported as 034960x and should be unknown, as the lot number reported by the customer is incorrect.
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Search Alerts/Recalls
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