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Model Number 1180300555 |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that one of their phlebotomist noticed the 3ml syringe was cracked, resulting in a redraw.
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Manufacturer Narrative
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Additional information: the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected from the lot.There were no samples submitted with this complaint.The reported condition was confirmed from a review of a picture provided of three syringes in an opened state.The exact root cause could not be determined as no documentation could be found that supported this type of failure.The investigation did not identify a systemic issue with the product or process, no trend exists for the failure mode, and a specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.
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Search Alerts/Recalls
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