Catalog Number 405138 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/14/2022 |
Event Type
Injury
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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.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 the bd whitacre¿ spinal needle was found "sheared off" when removing it from the epidural ligament.As a result, the patient's cardiac surgery was postponed, and general anesthesia was needed to extract the broken needle piece.The following information was provided by the initial reporter: "attempted spinal procedure with 27g whitacre.The needle was passed through the 20g introducer and advanced into the epidural ligament.No csf endpoint was obtained.The introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of the needle.The patient later had cardiac surgery.There were no long term adverse patient impact.Becton dickinson canada inc yes / oui canadian hospital specialties ltd (b)(6) 2022, pending assignment no / non a0401 - break / bris; e2403 - no clinical signs symptoms or conditions / aucun signe, symptôme ou condition cliniques; f19 - surgical intervention / intervention chirurgicale; f1909 - surgical procedure delayed / procédure chirurgicale retardée.
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Event Description
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It was reported that the bd whitacre¿ spinal needle was found "sheared off" when removing it from the epidural ligament.As a result, the patient's cardiac surgery was postponed, and general anesthesia was needed to extract the broken needle piece.The following information was provided by the initial reporter: "attempted spinal procedure with 27g whitacre.The needle was passed through the 20g introducer and advanced into the epidural ligament.No csf endpoint was obtained.The introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of the needle.The patient later had cardiac surgery.There were no long term adverse patient impact.Becton dickinson canada inc yes / (b)(6) hospital specialties ltd (b)(6) 2022; pending assignment no / non a0401 - break / bris; e2403 - no clinical signs symptoms or conditions / aucun signe, symptôme ou condition cliniques; f19 - surgical intervention / intervention chirurgicale; f1909 - surgical procedure delayed / procédure chirurgicale retardée.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the mdr 2618282-2022-00102 is a duplicate of 2618282-2022-00095 this supplemental is to cancel mdr 2618282-2022-00102.
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Search Alerts/Recalls
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