Model Number 10015414 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 19016977.Medical device expiration date: 2022-01-28.Device manufacture date: 2019-01-26.Medical device lot #: 19045971.Medical device expiration date: 2022-04-09.Device manufacture date: 2019-04-09.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 as lvp bld180m 15d dehp experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: i have received a notice that the blood administration sets appear to be turning a orange/red color within the tubing and filter area.
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Manufacturer Narrative
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H.6.Investigation: two samples were received for quality investigation.The customers complaint of cosmetic issue - discolored was verified by visual inspection.Evaluation of the samples submitted showed that the samples had a dark tint in the tubing that was throughout the infusion sets.A device history record review for model 10015414 lot number 19016977 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10015414 lot number 19045971 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this issue seen in this complaint is the sterilization process.Due to the sterilization process the infusion set tubing can get tinted.Additionally, the tinting of the tubing can be more visible throughout the infusion set with time.The discoloration does not affect the functionality and/or safety of the device.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of cosmectic issue - discolored with lot #19016977 regarding item #10015414.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of cosmectic issue - discolored with lot #19045971 regarding item #10015414.H3 other text : see h.10.
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Event Description
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It was reported that 2 as lvp bld180m 15d dehp experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: i have received a notice that the blood administration sets appear to be turning a orange/red color within the tubing and filter area.
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Search Alerts/Recalls
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