Catalog Number 385403-ZAT |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 saline wouldn't flow through the ext/red/1cq/mq/std/20cm before use while priming.The following information was provided by the initial reporter, translated from (b)(6) to english: "saline didn't flow, during priming.".
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Event Description
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It was reported that saline wouldn't flow through the ext/red/1cq/mq/std/20cm before use while priming.The following information was provided by the initial reporter, translated from japanese to english: "saline didn't flow, during priming.".
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Manufacturer Narrative
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H.6.Investigation summary: the end of the infusion set made by our company (lock connector) was connected to the actual product, and it was confirmed that the fluid passed through.Visual inspection was performed, but no abnormality such as damage or deformation was found.Since no abnormality was found in this product and reproducibility was not obtained, this event was presumed to have been a problem with the fitting part with the infusion set connected to this product.The incomplete connection and loosening of the mating part may have caused the q-site septum to open inadequately and the chemical solution may not flow.When connecting to an infusion set or syringe made by another company, the septum opening may be small due to differences in the length of the lock connector insertion part.The customer should be careful not to apply excessive load during use, and use the product while regularly checking for any looseness or disconnection of the connection or leakage of chemicals.A review of the device history record revealed no irregularities during the manufacture of the reported lot.H3 other text : see section h.10.
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Search Alerts/Recalls
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