Model Number 8881540111 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 when the anesthesia resident attached a blunt needle to a syringe with prefilled saline flush, the resident noticed that there was what appeared to be mold on the blunt needle.It did not reach the patient and the blunt needle was confiscated.
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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.Needle shop order numbers were reviewed and it was found that a non conformance (ncr) for inclusions was generated in the plastic components used.There were no samples returned with this complaint.A picture was submitted with the complaint and the reported condition could be confirmed.The failure reported is most likely inclusions of burnt acrylic plastic embedded into the cannula due to extended heating of the product during the molding process.A review of the molding process did not find any deviation within the temperature reaching outside of the validated parameter.The most likely root cause was prolonged downtime where the material was subjected to this heat causing the inclusions.As this was identified in the assembly process the most likely failure was due to incomplete containment of the nonconforming product.The investigation did not identify a systemic issue with the product or process, no trend exists for the failure mode and no failure could be confirmed.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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