Catalog Number 11000296 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the calibration marks of five (5) 20ml exactamed syringes were faded.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: upon further visual examination of the five (5) devices, the ink on the syringes appeared to be fading; however, the printing remained legible.The device malfunction does not affect the graduation/dosing marks and would not lead to an incorrect dose.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information was added to h3, h4 and h6.H4: lot manufactured during september 2020.H10: five (5) devices were received for evaluation.A visual inspection was performed which observed faded/missing print area defects on all of the syringe barrels in the same area circled in black marker by the customer.Functional testing was not performed.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.A batch review was conducted and a deviation was found related to the scale printing issue during the manufacture of this lot; the impacted units were discarded.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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