Catalog Number 306594 |
Device Problem
Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1322102.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.There are quality controls currently in place to detect this type of defect during the production process.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 during use with bd posiflush¿ pre-filled saline syringe the part of barrel was discovered to be damaged.There was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: at 10:20 am, when the nurse of the third department of internal medicine was preparing to seal the patient with indwelling needle, part of the needle barrel of the pre-filled catheter irrigator was found missing, which was immediately replaced without causing adverse effects to the patient.
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Event Description
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It was reported that during use with bd posiflush¿ pre-filled saline syringe the part of barrel was discovered to be damaged.There was no patient impact.The following information was provided by the initial reporter, translated from chinese to english: at 10:20 am, when the nurse of the third department of internal medicine was preparing to seal the patient with indwelling needle, part of the needle barrel of the pre-filled catheter irrigator was found missing, which was immediately replaced without causing adverse effects to the patient.
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Manufacturer Narrative
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H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1322102.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.H3 other text : see h.10.
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Search Alerts/Recalls
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