Model Number 367364 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown/ a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that bd vacutainer® ultratouch¿ push button blood collection set has holes in tubes.The following information was provided by the initial reporter.The customer stated: customer states product tubing has holes.This product is faulty, with some units having holes in the plastic tubing.This is a safety concern for both patient and employee, as this could cause blood leakage/spillage.
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Manufacturer Narrative
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The following fields have been updated with additional information: d.4.Medical device lot #: 1347947.D.4.Medical device expiration date: 31-aug-2023.D.9.Device available for eval? yes.D.9 returned to manufacturer on: 31-aug-2022.H.4.Device manufacture date: 13-dec-2021.H.6.Investigation summary: bd received 5 samples and 1 photo for investigation.The photo and samples were reviewed and the indicated failure mode for damaged/ cut tubing was observed.Additionally, 17 retention samples from bd inventory, were evaluated by visual examination and functional testing and upon completion the indicated failure mode for damaged/ cut tubing was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode damaged/ cut tubing.Bd has initiated further root cause investigation relating to the issue of damaged/ cut tubing through corrective and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.Our 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 bd vacutainer® ultratouch¿ push button blood collection set has holes in tubes.The following information was provided by the initial reporter.The customer stated: customer states product tubing has holes.This product is faulty, with some units having holes in the plastic tubing.This is a safety concern for both patient and employee, as this could cause blood leakage/spillage.
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Search Alerts/Recalls
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