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Model Number 1180320112 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/14/2019 |
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 during administering, leaking was noticed due to cracks in the body of the syringe.This was happened in the rheumatology department.There was no harm to the patient involved.
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Manufacturer Narrative
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There was no process related or material changes related to the reported condition for this product or describe changes that occurred.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the lot met all defined acceptance requirements and was released.A sample and a picture were provided for the evaluation.Upon visual evaluation, the reported condition is confirmed.A specific root cause of the reported condition could not be identified.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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