Catalog Number 306593 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 0364582.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd¿ pre-filled normal saline syringe was damaged and leaked during the flush.The following information was provided by the initial reporter, translated from (b)(6): "on the second day of puncture with the indwelling needle, the nurse connected the fluid and found that the indwelling needle was not dripping smoothly.The flush was used to prepare the indwelling needle to be flushed, and it was found that the outer packaging of the flush was damaged and leaking.Give immediate replacement of the precharge without air leakage and no damage, and re-flush.".
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Manufacturer Narrative
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 0364582.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd¿ pre-filled normal saline syringe was damaged and leaked during the flush.The following information was provided by the initial reporter, translated from (b)(6): "on the second day of puncture with the indwelling needle, the nurse connected the fluid and found that the indwelling needle was not dripping smoothly.The flush was used to prepare the indwelling needle to be flushed, and it was found that the outer packaging of the flush was damaged and leaking.Give immediate replacement of the precharge without air leakage and no damage, and re-flush.".
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Search Alerts/Recalls
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