Catalog Number 309646 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2019 |
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 air entered the bd luer-lok¿ syringe sterile, single use while pulling back the plunger to perform blood withdrawal.The following information was provided by the initial reporter: "bd 5 ml syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly.Customer performed the same procedure with the 10ml and 3ml and there were no issues.".
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Event Description
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It was reported that air entered the bd luer-lok¿ syringe sterile, single use while pulling back the plunger to perform blood withdrawal.The following information was provided by the initial reporter: "bd 5 ml syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly.Customer performed the same procedure with the 10ml and 3ml and there were no issues.".
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Manufacturer Narrative
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Investigation: one sealed shelf carton of 5ml syringes was received, confirmed to be from batch #8337846 (p/n 309646).The 125 syringes inside the shelf carton were visually evaluated.104 were found to have no defects, while 21 were observed to have minor tip damage on the edge of the tip.The damage observed was minor, visible only under magnification.All 125 samples were tested for leakage per procedure.All syringes passed with no leakage observed.The connection between the tip and needle was not compromised in any of the samples, therefore the minor damage observed is considered a cosmetic defect.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.
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Search Alerts/Recalls
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