Catalog Number 300865 |
Device Problems
Leak/Splash (1354); Free or Unrestricted Flow (2945)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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"there were two possible lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1908252, medical device expiration date: 2024-07-31, device manufacture date: 2019-08-05.Medical device lot #: 1908254, medical device expiration date: 2024-07-31, device manufacture date: 2019-08-05." 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 syringe was damaged and air leakage occurred during use with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: we have had another incident where a damaged syringe has caused a rapid infusion of medicine, (in this case insulin) and potential air infiltration ¿ no harm came to the patient.
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Manufacturer Narrative
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H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the suspected lots 1908252 and 1908254 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Six retained samples of lots 1908252 and 1908254 were used for additional evaluation.The product was visually inspected, no defects or damage was identified.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.
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Event Description
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It was reported that syringe was damaged and air leakage occurred during use with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: we have had another incident where a damaged syringe has caused a rapid infusion of medicine, (in this case insulin) and potential air infiltration ¿ no harm came to the patient.
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Search Alerts/Recalls
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