Catalog Number 382544 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, 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 insyte¿ autoguard¿ bc shielded iv catheter had foreign matter.No serious injury or medical intervention was reported.Verbatim: "before using the catheter the staff member observed that there was some extra vialon material at the end of the catheter.They then abandoned the cannulation and used another cannula.".
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had foreign matter.No serious injury or medical intervention was reported.Verbatim: "before using the catheter the staff member observed that there was some extra vialon material at the end of the catheter.They then abandoned the cannulation and used another cannula.".
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Manufacturer Narrative
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Investigation summary: the dhr review was not performed since the lot number related to this investigation was unknown.Received one 18ga iag bc catheter-adapter assembly with no packaging material.Visual examination: ¿the needle had speared through the catheter tubing.¿a v-shaped cut left by the needle tip was observed near the catheter tip.¿the remainder cut off of the catheter tubing (non-foreign) was attached to the catheter tip.Conclusion(s): the defect found on the catheter tip was caused by the manufacturing process (tipping) of the product.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators to ensure process changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.
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Search Alerts/Recalls
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