Catalog Number 309597 |
Device Problems
Break (1069); Entrapment of Device (1212); Product Quality Problem (1506); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7309904; medical device expiration date: 2022-10-31; device manufacture date: 2017-11-05; medical device lot #: 8059526; medical device expiration date: 2023-02-28; device manufacture date: 2018-02-28.
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Event Description
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It was reported that an unspecified number of syringe 1ml s/t w/ndl 26x5/8 rb experienced needle breakage inside patient.The following information was provided by the initial reporter: material no.309597, batch no.7309904 and 8059526.(2 out of 2).Patient claims that syringe and needle provided in the kit for injection is horrible.Has trouble drawing up and states needles have previously come off syringe and got stuck in his leg.
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Manufacturer Narrative
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Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.
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Event Description
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It was reported that an unspecified number of syringe 1ml s/t w/ndl 26x5/8 rb experienced needle breakage inside patient.The following information was provided by the initial reporter: material no.309597, batch no.7309904 and 8059526.(2 out of 2).Patient claims that syringe and needle provided in the kit for injection is horrible.Has trouble drawing up and states needles have previously come off syringe and got stuck in his leg.
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Search Alerts/Recalls
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