Model Number 383312 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/15/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported that patient had infection at the insertion site with a bd saf-t-intima iv catheter safety system.The following information was provided by the initial reporter, translated from (b)(6) to english: head nurse of the (b)(6), during the infusion of indwelling needles in the ward in (b)(6) 2020, she found that indwelling needle appeared puncture site infection in the last 10 days.The customer suspected that the indwelling needles were related to the indwelling needles.
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Event Description
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It was reported that patient had infection at the insertion site with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from chinese to english: head nurse of the department of general medicine, during the infusion of indwelling needles in the ward in (b)(6) 2020, she found that indwelling needle appeared puncture site infection in the last 10 days.The customer suspected that the indwelling needles were related to the indwelling needles.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was performed for provided lot number 9031833.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this issue, two picture samples were received for evaluation by our quality engineer team; however, through examination of the picture samples alone, the reported incident could not be confirmed.The certification of sterilization for this lot number was reviewed and the sterilization process met all of the criteria for acceptance.At this time, a manufacturing related cause could not be determined for this incident.H3 other text : see h.10.
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Search Alerts/Recalls
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