Model Number 309657 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2021 |
Event Type
malfunction
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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.Initial reporter name and address: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1104797, medical device expiration date: 2026-04-30 , device manufacture date: 2021-06-01.Medical device lot #: 1043500, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-30.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 2 bd 60ml syringe luer-lok¿ tips experienced incorrect label information.The following information was provided by the initial reporter: it was reported by the medical professional, the boxes have different packaging and they are two different sizes with the same reference number.
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Event Description
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It was reported that 2 bd 60ml syringe luer-lok¿ tips experienced incorrect label information.The following information was provided by the initial reporter: it was reported by the medical professional, the boxes have different packaging and they are two different sizes with the same reference number.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Search Alerts/Recalls
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