Catalog Number 383335 |
Device Problems
Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd saf-t-intima¿ closed iv catheter system the sterility was compromised and the product was broken.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the child neurology teacher sent the product to the equipment department, and the equipment department reported that before opening the package of the product, it was found that the outer package was burned by high temperature, resulting in cracking of the product.The outer package was deformed, and the plastic packaging inside was melted, which was no longer sterile.
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Manufacturer Narrative
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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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Event Description
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It was reported while using bd saf-t-intima¿ closed iv catheter system the sterility was compromised and the product was broken.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the child neurology teacher sent the product to the equipment department, and the equipment department reported that before opening the package of the product, it was found that the outer package was burned by high temperature, resulting in cracking of the product.The outer package was deformed, and the plastic packaging inside was melted, which was no longer sterile.
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of package defective/damaged was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.See h10.
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Search Alerts/Recalls
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