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Catalog Number 300865 |
Device Problem
Crack (1135)
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Patient Problem
Loss of consciousness (2418)
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Event Date 04/24/2023 |
Event Type
Injury
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Event Description
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It was reported while using bd plastipak¿ syringes the product was damaged and air entered the line.The following information was provided by the initial reporter, translated from french to english: potential lot numbers: 2303013 or 2303053 or 2206024 or 2202033.Verbatim: the patient was found unconscious at 8 o'clock.Air is found in the tubing.Then we find that the syringe of the midazolam eps is full of air.The syringe is cracked.In addition to the air leak, the crack accelerated the passage of the drug in iv (approximately 30mg of midazolam in 24 hours).Patient found unconscious.After stopping the pes and treatment with naloxone and flumazenil the patient responded to the calls.Then transfer to palliative care, recovery and no long term consequences.
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-aug-2023.H6: investigation summary: one syringe sample received by our quality team for investigation.Through visual evaluation, the barrel is cracked, therefore the incident is confirmed.A device history review was performed for the possible lot numbers 2303013, 2303053, 2206024 and 220203, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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 teams investigation, root cause of the incident is related with a hit during transport or manufacturing.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.
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Event Description
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It was reported while using bd plastipak¿ syringes the product was damaged and air entered the line.The following information was provided by the initial reporter, translated from french to english: potential lot numbers: 2303013 or 2303053 or 2206024 or 2202033.Verbatim: the patient was found unconscious at 8 o'clock.Air is found in the tubing.Then we find that the syringe of the midazolam eps is full of air.The syringe is cracked.In addition to the air leak, the crack accelerated the passage of the drug in iv (approximately 30mg of midazolam in 24 hours) patient found unconscious.After stopping the pes and treatment with naloxone and flumazenil the patient responded to the calls.Then transfer to palliative care, recovery and no long term consequences.
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Search Alerts/Recalls
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