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Catalog Number 301948 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 10/27/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported that the syringe s2 20ml 18ga 1-1/2in bd (b)(6) leaked blood during use, and those exposed received medical intervention as a result.The following information was provided by the initial reporter, translated from (b)(6) to english: the head nurse complained to the equipment department, the dealer contacted their company, material number (b)(4), batch number: 1904134, during the dialysis reinfusion process of the syringe, the syringe leaked, the syringe pump gave frequent alarms, and the leakage of blood caused the risk of doctor-patient cross-infection.The department nurses responded strongly and refused to use the product, and the remaining syringes in the department have been removed."people who were injured or exposed to blood/body fluids received medical intervention because of the incident".
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Event Description
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It was reported that the syringe s2 20ml 18ga 1-1/2in bd china leaked blood during use, and those exposed received medical intervention as a result.The following information was provided by the initial reporter, translated from chinese to english: the head nurse complained to the equipment department, the dealer contacted their company, material number 301948 20ml, batch number: 1904134, during the dialysis reinfusion process of the syringe, the syringe leaked, the syringe pump gave frequent alarms, and the leakage of blood caused the risk of doctor-patient cross-infection.The department nurses responded strongly and refused to use the product, and the remaining syringes in the department have been removed."people who were injured or exposed to blood/body fluids received medical intervention because of the incident".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was performed for provided lot number 1904134 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.All inspections performed during the production process were within specification.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, leakage was observed through the plunger rod component.Damage was identified to the plunger rod through magnified inspection.No signs of leakage were identified in the other fifty-three representative samples returned in addition to the affected sample.It has been determined that the leakage resulted from damage to the plunger lip component.This type of damage can result during the handling of the product throughout the manufacturing facility or during the plunger assembly process.
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Search Alerts/Recalls
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