Model Number 328512 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 wal experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.328512, batch no.9168970.Verbatim: issue: pet owner reported when she opened the package one of the syringe barrel was filthy and dirty inside the barrel.This happened couple of days ago.She stated she uses the 31g, 8mm, 3/10 syringes for her pet.Sample available.Item# 328512, lot# 9168970.Pet owner always uses the new needle for its injection.She visually test the needle to see if it is straight.Offered to send the replacement, she refused to get the replacement.
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Manufacturer Narrative
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Investigation: no samples (including photos) were returned as of (b)(6) 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9168970.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for fm in barrel.
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Event Description
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It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 wal experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.328512 batch no.9168970.Verbatim: issue: pet owner reported when she opened the package one of the syringe barrel was filthy and dirty inside the barrel.This happened couple of days ago.She stated she uses the 31g, 8mm,3/10 syringes for her pet.Sample available.Item# 328512, lot# 9168970.Pet owner always uses the new needle for its injection.She visually test the needle to see if it is straight.Offered to send the replacement, she refused to get the replacement.
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Search Alerts/Recalls
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