Model Number SYRINGES |
Device Problem
Material Separation (1562)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 02/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-61 -improper use / mishandled by end user.Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the product was replaced by the pharmacy and they have not had any medical intervention or symptoms since the last call.Customer gave the syringes in question to the pharmacy.
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Event Description
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Consumer reported complaint for needle separate while using syringe.Customer is not claiming injury but states that she had a bruise.States she used four syringes and they all gave her the same issue.Customer states the needle came off the syringe after administering the insulin and while pulling away from the injection site.The plunger was fine and that the syringe was not bent or broken.Customer states the needle came off the syringe after administering the insulin and confirmed that the insulin did not leak out of the syringe.Customer was able to administer the insulin accordingly.Customer states there were no leaks from the syringe and therefore there was no lapse in the administration of her insulin.Customer did not have to seek medical attention.
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = f) internal report #: (b)(4).Product returned and investigated with no defect found.Most likely underlying root cause: mlc-61 -improper use / mishandled by end user.Note: manufacturer contacted customer on 2/13/2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the product i was replaced by the pharmacy and they have not had any medical intervention or symptoms since the last call.Customer gave the syringes in question to the pharmacy.
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Event Description
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Consumer reported complaint for needle separate while using syringe.Customer is not claiming injury but states that she had a bruise.States she used four syringes and they all gave her the same issue.Customer states the needle came off the syringe after administering the insulin and while pulling away from the injection site.The plunger was fine and that the syringe was not bent or broken.Customer states the needle came off the syringe after administering the insulin and confirmed that the insulin did not leak out of the syringe.Customer was able to administer the insulin accordingly.Customer states there were no leaks from the syringe and therefore there was no lapse in the administration of her insulin.Customer did not have to seek medical attention.
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Search Alerts/Recalls
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