Model Number 329420 |
Device Problem
Defective Device (2588)
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Patient Problem
No Code Available (3191)
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Event Date 03/23/2020 |
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.
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Event Description
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It was reported that syringe 1.0ml 28ga 1/2in bls 500 sus ca needle separated from the hub and patient went to the er and received x-rays to determine if the needle remained in his arm.The following information was provided by the initial reporter: "it was reported that after the injection the patient and person administering noted that the needle was missing.After going to the er and having an x-ray performed, it was confirmed that no needle was present in the patient's arm.The syringe was x-rayed and it indicated that the needle was in the barrel of the syringe.".
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Event Description
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It was reported that syringe 1.0ml 28ga 1/2in bls 500 sus ca needle separated from the hub and patient went to the er and received x-rays to determine if the needle remained in his arm.The following information was provided by the initial reporter: "it was reported that after the injection the patient and person administering noted that the needle was missing.After going to the er and having an x-ray performed, it was confirmed that no needle was present in the patient's arm.The syringe was x-rayed and it indicated that the needle was in the barrel of the syringe.".
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Manufacturer Narrative
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H.6.Investigation: no samples were returned as of 23 april 2020 therefore the investigation was performed based on the photos provided.Customer provided two (2) photos of a 1ml bd insulin syringe from lot 4160731.It was reported that after the injection the patient and person administering noted that the needle was missing.Both photos were reviewed and no evidence of manufacturing defect could be determined from the photos provided.Since no defects were observed in the provided photos the alleged issues could not be confirmed.A review of the device history record was completed for batch # 4160731.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.
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Search Alerts/Recalls
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