Model Number 309628 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Visual Impairment (2138)
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Event Date 10/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7291739.Medical device expiration date: 2022-09-30.Device manufacture date: 2017-11-02.Medical device lot #: 8057806.Medical device expiration date: 2023-02-28.Device manufacture date: 2018-04-17.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that an unspecified number of syringe 1ml ll w/o dn experienced foreign matter contamination which was noted prior to use.The reported defect led to a serious injury in the form of vision impairment/ocular inflammation.The following information was provided by the initial reporter: material no.: 309628 batch no.: 7291739, 8057806.Complaint 1 of 3: this complaint is for 1ml syringe cat # 309628.Per complaint: we are faced with a technical complaint where the doctor observed that after ocular injection silicone or silicon like droplets were present in the eye of the patient which claimed in 3 of 4 cases about eye inflammation.Additionally the doctor noticed "small metallic, irregularly shaped shimmering flakes floating in the anterior vitreous".The auxiliary material was provided from distributor and manufactured at bd.They observed after ocular injection using the syringes and needles provided from bd , silicon oil droplets and metallic flakes in the eye of the patient.These observations were connected with an inflammation of the eyes of patients.Furthermore we were notified that it can be a general issue that silicone oil droplets are extracted from the syringe onto the product dosed.
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Event Description
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It was reported that an unspecified number of syringe 1ml ll w/o dn experienced foreign matter contamination which was noted prior to use.The reported defect led to a serious injury in the form of vision impairment/ocular inflammation.The following information was provided by the initial reporter: material no.: 309628, batch no.: 7291739, 8057806.Complaint 1 of 3: this complaint is for 1ml syringe cat # 309628.Per complaint: we are faced with a technical complaint where the doctor observed that after ocular injection silicone or silicon like droplets were present in the eye of the patient which claimed in 3 of 4 cases about eye inflammation.Additionally the doctor noticed "small metallic, irregularly shaped shimmering flakes floating in the anterior vitreous".The auxiliary material was provided from distributor and manufactured at bd.They observed after ocular injection using the syringes and needles provided from bd , silicon oil droplets and metallic flakes in the eye of the patient.These observations were connected with an inflammation of the eyes of patients.Furthermore we were notified that it can be a general issue that silicone oil droplets are extracted from the syringe onto the product dosed.
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Manufacturer Narrative
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The following field was updated due to corrected information: h.1.Type of reportable events: serious injury.H.6.Investigation: two photos and twenty-five representative samples consisting of 1ml syringes in fully sealed blister packs from batch 7291739 (p/n 309628) were received and evaluated.The silicone observed in all the syringes received, was the normal and expected amount per product specification.Based on the information available today potential root cause for the reported defect could not be attributed to the syringe manufacturing process at this time.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.H3 other text : see h.10.
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Search Alerts/Recalls
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