Model Number SYRINGES |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Returned syringes evaluated with defect found.Qc visually inspected returned syringes on 1/9/2018; 7 out of 7 syringes observed bent needle.Qc disposition: forward returned products to supply chain for further investigations.Most likely underlying root cause: mlc-61 -improper use/ mishandled by end user.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern was resolved - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
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Event Description
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Consumer reported complaint for bent needle.Customer called to report she purchased two boxes of syringes and states that some of the syringes needle are bent.Customer was advised to send us the bent needle to investigate and refer back to the pharmacy for replacement.The customer did not report symptoms.Medical attention is not reported as a result of bent needle.
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned syringes evaluated with defect found.Qc visually inspected returned syringes on 1/9/2018; 7 out of 7 syringes observed bent needle.Qc disposition: forward returned products to supply chain for further investigations (by product manufacturer).Rc-003 other: supplier manufacturing defect.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern was resolved - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.Note 2: manufacturer conducted a test on retention samples for product 15 days before and after of the lot manufactured and confirmed that there aren't needle bent for each lot.Customer complaint and returned product were sent to the product manufacturer for additional investigation.The inspection machine can take out a faulty product which needle is inserted obliquely on the cylinder tip, neither the machine or the worker recognized the problem.
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Event Description
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Consumer reported complaint for bent needle.Customer called to report she purchased two boxes of syringes and states that some of the syringes needle are bent.Customer was advised to send us the bent needle to investigate and refer back to the pharmacy for replacement.The customer did not report symptoms.Medical attention is not reported as a result of bent needle.
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Search Alerts/Recalls
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