BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER PLASTIC THROMBIN TUBE WITH ORANGE HEMOGARD CLOSURE
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Catalog Number 367811 |
Device Problems
Leak/Splash (1354); Product Quality Problem (1506)
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Patient Problems
Exposure to Body Fluids (1745); Injury (2348)
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Event Date 05/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 during us a bd vacutainer plastic thrombin tube with orange hemogard closure malfunctioned as "the nurse assembled the wingset with the luer and the holder, then did the venipuncture.She inserted the tube in the holder and after a while she noticed that the blood was getting out.Then she observed the tube and the bottom was missing.Due to the force applied on the missing bottom, the irregular margins of the tube broke the glove and injured a little her skin, that was therefore in contact with the patient¿s blood." upon further investigation it was found "the nurse told me that the blood was not infected." there was no report of medical intervention needed.
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed relating to molding defect as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on evaluation of the retain samples, the customer¿s indicated failure mode for molding defect with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The retained product was found to be in conformance and meet release specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business 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 us a bd vacutainer plastic thrombin tube with orange hemogard closure malfunctioned as "the nurse assembled the wingset with the luer and the holder, then did the venipuncture.She inserted the tube in the holder and after a while she noticed that the blood was getting out.Then she observed the tube and the bottom was missing.Due to the force applied on the missing bottom, the irregular margins of the tube broke the glove and injured a little her skin, that was therefore in contact with the patient¿s blood." upon further investigation it was found "the nurse told me that the blood was not infected." there was no report of medical intervention needed.
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Search Alerts/Recalls
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