Catalog Number 30965780 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 bd luer-lok¿ tip disposable syringe packaging was found unsealed before use.The following information was provided by the initial reporter: "the inside of the package has a black section that your plastic wrapper is unable to seal to.The initial notification stated the syringes do not seal on the black part, was there leakage? it makes the product unsterile because the packaging is not sealed.".
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Manufacturer Narrative
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H6: investigation summary: one packaging sample for lot #2306440 was received for investigation.Returned sample received.On march 08, 2023.A black square can be seen on the packaging.The complaint can be confirmed.A review of the device history record was completed for batch #2306440.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
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Event Description
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It was reported that the bd luer-lok¿ tip disposable syringe packaging was found unsealed before use.The following information was provided by the initial reporter: "the inside of the package has a black section that your plastic wrapper is unable to seal to.The initial notification stated the syringes do not seal on the black part, was there leakage? it makes the product unsterile because the packaging is not sealed".
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Search Alerts/Recalls
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