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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Device manufacturer postal code: (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 two (2) 20ml exactamed syringes were faded.This issues 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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H4: lot manufactured during september 2020.H10: two (2) actual devices were received for evaluation.A visual inspection was performed and faded/missing print defects was observed on both of the syringe barrels.Functional testing was not performed for this complaint.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 there were no deviations found related to this reported condition during the manufacture of this lot.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 h10.H10: upon further visual examination of the two (2) 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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Search Alerts/Recalls
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