Catalog Number UNKNOWN |
Device Problems
Crack (1135); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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They get complaints about the 5 and 10ml syringes.There are cracks in the plastic housing through which the liquid leaks.Additional information: but i would like to inform you that the syringes are not used in the medical sector (on patients).The syringes are used only by commercial laboratories (in combination with syringe filters).
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Manufacturer Narrative
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As no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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