Catalog Number 309659 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd¿ slip-tip disposable tuberculin syringe had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309659 batch no: 9007849.It was reported that the product inside the syringe looked cloudy.Event description per customer's attached email states, "product inside syringe looks cloudy".
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Manufacturer Narrative
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H.6.Investigation: one resealed shelf carton was received, containing 200 sealed packaged 1ml s/t syringes from batch #9007849 (p/n 309659).The syringes were visually evaluated.37 out of 200 were found to have cloudy tips.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Cloudy tips are a result of normal molding process.Over time a small amount of plastic build up or residue occurs in the mold causing this defect.It is remedied by polishing the mold.The cloudy tip defect is cosmetic and does not pose risk to the customer.
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Event Description
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It was reported that bd¿ slip-tip disposable tuberculin syringe had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309659 batch no: 9007849.It was reported that the product inside the syringe looked cloudy.Event description per customer's attached email states, "product inside syringe looks cloudy".
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Search Alerts/Recalls
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