| Catalog Number 6301182010 |
| Device Problems
Contamination /Decontamination Problem (2895); Insufficient Information (3190)
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| Patient Problems
Foreign Body Sensation in Eye (1869); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 01/16/2024 |
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Event Type
Injury
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Event Description
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During the operation, syringes black threads or particles always flow into the eye directly at the beginning [foreign body in eye] some of the syringes there are black threads or particles [device use issue] case narrative: case (b)(4) is a serious spontaneous case received from other healthcare professional in germany.This report concerns a patient (no patient identifiers reported) of unknown age and gender who experienced the presence of black threads or particles in some of the biolon prime syringes and during operation, syringes black threads or particles always flow into the eye directly at the beginning during treatment with biolon prime (sodium hyaluronate) 12 mg/ml solution for injection, with an unknown dose and route of administration, for an unspecified indication from an unknown start date to an unknown stop date.Lot number: u14998aa and expiration date: oct-2025.It was reported that some biolon prime syringes contained black threads or particles.During the operation, these consistently flowed directly into the eye at the beginning, with the first input.The doctor had to bring the patient back to the operating room (or) several days after the lens implantation because a thread had been left in the eye, obstructing the patient's field of view, and needed to be removed.The doctors had several times mentioned about particles and threads to the reporter but had been unable to show it or capture any of the particles.On (b)(6) 2024, the reporter attended the operating room and observed that they were able to take a photo and save the syringe.The some of the syringes there are black threads or particles and during operation, syringes black threads or particles always flow into the eye directly at the beginning was medically significant.Manufacturer's preliminary comments: a.~for initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation: investigation was started according to initial information received from complaint reporter (nordic pharma distributer) and logged in as complaint qr #(b)(4) in trackwise.Since the investigation is on-going and elementary data is missing, no conclusion can be established yet.The reporter was contacted several times in order to receive the required information to complete the investigation and to achieve preliminary results.B.~initial actions (corrective and/or preventive) implemented by the manufacturer: elementary data is missing to evaluate the case impact, upon receiving of further information and/or preliminary investigation conclusion initial action will be defined.C.~what further investigations do you intend in view of reaching final conclusions? testing of lot retention samples, batch record review, re-occurrence, trending, etc.Cause investigation and conclusion: results of the assessment: according to 'euflexxa and biolon product family hazard master list' (btg-val-030609) this event, taking into consideration worst case scenario, is classified as s3.Action taken to biolon was unknown.No concomitant medication was reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = cn (b)(4).Internal # - others = #(b)(4).This ae occurred in germany (eu) and concerns the medical device biolon prime.Please report to your local health authority if required by local law.No corrective action was done by the manufacturer or requested by regulators.
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Event Description
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During the operation, presence of particles and threads look black always flow into the eye directly at the beginning [foreign body in eye] some of the syringes there are looks black threads or particles [device use issue] case narrative: (b)(4) is a serious spontaneous and complaint case received from a healthcare professional in germany.This report concerns a patient (no patient identifiers reported) of unknown age and gender who was brought back to the operating room (or) several days after eye surgery where biolon prime (sodium hyaluronate) 12 mg/ml solution for injection was used during the procedure.Lot number: u14998aa and expiration date: oct-2025.On 16-jan-2024, manufacturer received a complaint in which in some biolon prime syringes, particles and threads were observed.It was reported that during the operation, these consistently flowed directly into the eye at the beginning, with the first input.The doctors had several times mentioned about these particles and threads to the reporter but had been unable to show any of the particles.On (b)(6) 2024, the reporter attended the operating room (or) and observed that they were able to take a photo and save the pre-filled syringe.On (b)(6) 2024, manufacturer's preliminary investigation results, indicated a thorough review of all aspects of the manufacturing process.This encompassed an examination of manufacturing batch records, formulation and filling processes, ethylene oxide (eto) sterilization, visual inspection, and packaging steps.No unusual events were identified during the production of this lot.The visual inspection results were carefully analyzed, and the rejection rate trends were found to be well within acceptable limits, successfully passing the acceptable quality level (aql) standards.There were no adverse trends detected, and the rejection rate remained within established parameters.On the same day, sterimedix (cannula supplier) investigated regarding contamination.Despite examining picture evidence, they could not pinpoint the contamination's source or nature.The contamination did not match known instances of thread contamination; it varied in thickness and appeared broken, unlike a continuous thread.The investigation concluded that the foreign material could not have entered during the manufacturing process.Sterimedix could not identify any specific materials or processes used during manufacturing, both at their end and by their suppliers, suggesting the issue did not arise in their production.On 09-feb-2024, it was reported that a thread was hidden in the corner of the eye and was only flushed forward days later by the natural aqueous humor flow.This thread was then attached on the intraocular lens in the patient's field of vision which was disturbing the view.Several days after the lens implantation, the patient had to go back to the operating room to have the thread rinsed out and aspirated on an unknow date.On 09-feb-2024, nordic pharma shared details about a red shining part in the equipment with a diameter of approximately 6mm.The incident involved long particles visible to the naked eye and smaller ones under a microscope.The particles and threads look black in the ophthalmic microscope.The doctor uses during the or a red reflex illumination from bottom(retina) to the top which gives him the chance to distinguish the different transparent layers of the eye.In consequence particles are also illuminated from the backside and you see their shadow.So, the optical impression was black.This makes clear that the particles were no transparent structure but tells us nothing about the real colour.Under microscope light the real colour which can also be blue, green or grey.Fortunately, these threads or particles did not lead to any complications like endophthalmitis, inflammation, tass syndrome, or irritation for the patients.The investigation concluded that the observed practice in the complaint was 2.5-3mm long and easily detectable during visual inspection.The lot underwent the necessary visual inspection and successfully passed aql testing.Consequently, it was deemed unlikely that this particle was related to btg's manufacturing processes.On 12-feb-2024, the manufacturer's final investigation concludes that there was no relation between the complaint issue to the syringe barrels supplied by bd.There was no relation between the complaint issue to the cannulas supplied sterimedix.The events of 'foreign body in eye' and 'device use issue' were assessed as medically significant.Action taken to biolon prime was unknown.No concomitant medication was reported.The outcome of 'foreign body in eye' and 'device use issue' was recovered.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = (b)(4).Internal # - complaint = (b)(4).This ae occurred in germany (eu) and concerns the medical device biolon prime.Please report to your local health authority if required by local law.No corrective action was done by the manufacturer or requested by regulators.Correction 30-jan-2024: event onset date has been updated from unknown to 14-jan-2024.Added preliminary comment in device tab and expected date of follow up report under eu/ca device section.Update the narrative accordingly with status of investigation.Additional information received on 05-feb-2024, 06-feb-2024 and 09-feb-2024 from nordic pharma: new imrdf codes, specifically b12, b14, b15, b17, b18, b02, and a26, were added to the device tab.Update the description as reported for the events.The patient reporter details were added.The investigation summary has been incorporated into the case.Case narrative updated accordingly.
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Manufacturer Narrative
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Investigation ongoing 0.
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Manufacturer Narrative
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Investigation ongoing.
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Event Description
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During the operation, syringes black threads or particles always flow into the eye directly at the beginning [foreign body in eye].Some of the syringes there are black threads or particles [device use issue].Case narrative: case (b)(4) is a serious spontaneous case received from other healthcare professional in germany.This report concerns a patient (no patient identifiers reported) of unknown age and gender who experienced the presence of black threads or particles in some of the biolon prime syringes and during operation, syringes black threads or particles always flow into the eye directly at the beginning during treatment with biolon prime (sodium hyaluronate) 12 mg/ml solution for injection, with an unknown dose and route of administration, for an unspecified indication from an unknown start date to an unknown stop date.Lot number: u14998aa and expiration date: oct-2025.On 14-jan-2024, it was reported that some biolon prime syringes contained black threads or particles.During the operation, these consistently flowed directly into the eye at the beginning, with the first input.The doctor had to bring the patient back to the operating room (or) several days after the lens implantation because a thread had been left in the eye, obstructing the patient's field of view, and needed to be removed.The doctors had several times mentioned about particles and threads to the reporter but had been unable to show it or capture any of the particles.On (b)(6) 2024, the reporter attended the operating room and observed that they were able to take a photo and save the syringe.The some of the syringes there are black threads or particles and during operation, syringes black threads or particles always flow into the eye directly at the beginning was medically significant.The investigation into the complaint is currently ongoing, following the practical problem solving (pps) methodology.The investigation has encompassed the review of all manufacturing batch records, formulation and filling processes, ethylene oxide (eto) sterilization, visual inspection, and packaging steps.Additionally, the team has reviewed visual inspection results, analyzed visual inspection rejection rate trends, conducted re-inspection (visual inspection) for reserve samples ((b)(4) units), traced syringe barrels and cannulas used in the production of this lot, searched for previous complaints related to this lot, and investigated previous complaints for the same issue.Manufacturer's preliminary comments: a.~for initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation: investigation was started according to initial information received from complaint reporter (nordic pharma distributer) and logged in as complaint qr #(b)(4) in trackwise.Since the investigation is on-going and elementary data is missing, no conclusion can be established yet.The reporter was contacted several times in order to receive the required information to complete the investigation and to achieve preliminary results.B.~initial actions (corrective and/or preventive) implemented by the manufacturer: elementary data is missing to evaluate the case impact, upon receiving of further information and/or preliminary investigation conclusion initial action will be defined.C.~what further investigations do you intend in view of reaching final conclusions? testing of lot retention samples, batch record review, re-occurrence, trending, etc.Cause investigation and conclusion: results of the assessment: according to 'euflexxa and biolon product family hazard master list' (btg-val-030609) this event, taking into consideration worst case scenario, is classified as s3.Action taken to biolon was unknown.No concomitant medication was reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = (b)(6).Internal # - others = #(b)(4).This ae occurred in germany (eu) and concerns the medical device biolon prime.Please report to your local health authority if required by local law.No corrective action was done by the manufacturer or requested by regulators.Correction 30-jan-2024: event onset date has been updated from unknown to 14-jan-2024.Added preliminary comment in device tab and expected date of follow up report under eu/ca device section.Update the narrative accordingly with status of investigation.
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Search Alerts/Recalls
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