MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. BIOLON; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Eye Injury (1845)

Event Date 08/29/2019

Event Type  Injury  

Event Description

Tear to the anterial chamber [anterior chamber disorder].During surgery the biolon needle detached from the syringe [device connection issue].Case (b)(4) is a serious spontaneous case received from a nurse in (b)(6).This report concerns a (b)(6) caucasian female who experienced tear to the anterial chamber during treatment with biolon (sodium hyaluronate) solution for injection, on (b)(6) 2019.Lot number: p14511ca.Concentration, dose and indication were not reported.On (b)(6) 2019 from 14:06 to 14:25, during surgery the biolon needle detached from the syringe whilst the surgeon was using it (device connection issue).The syringe filled with biolon and a ray croft needle was attached with lure lock.The clear attachment to the syringe revolved as the needle was being secured.The plastic round tip kept revolving and did not lock.The cannula detached itself during surgery, causing a tear to the anterial chamber.It was confirmed, that the hospital staff used the correct cannula provided with biolon.The cannula detachment during surgery, causing a tear to the anterial chamber was medically significant.Action taken to biolon was unknown.At initial reporting time, the outcome of the tear to the anterial chamber was unknown.No concomitant medication was reported.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # affiliate: (b)(4).This ae occurred in united kingdom and concerns the medical device biolon.Please report to your local health authority if required by local law.This ae is reportable in eu because it meets the definition of a medical device incident according to the requirements of the medical device directive and occurred in a eu + efta country.No corrective action was done by the manufacturer or requested by regulators.

Event Description

During surgery the biolon needle detached from the syringe [device connection issues] case (b)(4) is a serious spontaneous complaint case received from a nurse in united kingdom.This report concerns an 83-year-old caucasian female who, during surgery, experienced the biolon needle detached from the syringe during treatment with biolon (sodium hyaluronate) solution for injection, on (b)(6) 2019.Lot number: p14511ca.Concentration, dose and indication were not reported.On (b)(6) 2019 from 14:06 to 14:25, during surgery the biolon needle detached from the syringe whilst the surgeon was using it (device connection issue).The syringe filled with biolon and a ray croft needle was attached with lure lock.The clear attachment to the syringe revolved as the needle was being secured.The plastic round tip kept revolving and did not lock.The cannula detached itself during surgery.It was confirmed, that the hospital staff used the correct cannula provided with biolon.The cannula detachment during surgery was medically significant.Conclusion from complaint management report (qa track): root cause could not be concluded.Release of all affected batches.The complaint's investigation did not reveal any quality issue related to btg processes or raw materials.There are differences in the strengths of the connection of the luer lock (lla) to the barrel allowing a free rotation of the luer lock.This causes the doctor/nurse to believe that the cannula is not attached properly and further rotation of the cannula is required.Additional rotation of the cannula causes weakening of the cannula- barrel connection, which might result in detachment of the cannula during use.In order to enable proper assembly of the cannula and in order to prevent cannula detachment, it is mandatory to follow the instruction specified in the product leaflet and verify that the cannula is tightened to the barrel, meaning that the doctor / nurse must twist it to its position until it stops.If the lla doesn't stop, the doctor / nurse must hold the white lla in his / her fingers in one hand, while twisting the cannula base to its position until it stops in his / her second hand.In order to improve needle assembly to the syringe, btg produced detailed instruction videos in english which detail the correct assembly procedure of the needle into the syringe.Btg is convinced that this instruction movie will improve the needle assembly procedure by the physicians and will prevent similar complaints in the future.Action taken to biolon was unknown.At initial reporting time, the outcome was unknown.No concomitant medication was reported.Overall listedness (core label) is listed.Reporter causality: related.Company causality: related.Sender comment (ferring): this case is considered a 'near incident' as it might have lead to a serious injury.Company causality is related.Based on the conclusion of the complaint management report it seems possible that inappropriate preparation of the device could have been a contributing factor.Other case numbers: internal # - affiliate = (b)(4).Internal # - complaint = (b)(4).This ae occurred in united kingdom and concerns the medical device biolon.Please report to your local health authority if required by local law.This ae is reportable in eu because it meets the definition of a medical device incident according to the requirements of the medical device directive and occurred in a eu + efta country.No corrective action was done by the manufacturer or requested by regulators.Conclusion from complaint management report (qa track) received 07 nov 2019: updated narrative, added additional qa track number ((b)(4)).Additional information received on 21-nov-2019: based on the information received from the nurse that 'the patient did not experience a tear to the anterior chamber, or any other complication' the event 'tear to the anterial chamber' was removed, narrative updated accordingly.

Event Description

Tear to the anterial chamber [anterior chamber disorder].During surgery the biolon needle detached from the syringe [device connection issue].Case (b)(6) is a serious spontaneous complaint case received from a nurse in united kingdom.This report concerns an 83-year-old caucasian female who experienced tear to the anterial chamber during treatment with biolon (sodium hyaluronate) solution for injection, on (b)(6) 2019.Lot number: p14511ca.Concentration, dose and indication were not reported.On (b)(6) 2019 from 14:06 to 14:25, during surgery the biolon needle detached from the syringe whilst the surgeon was using it (device connection issue).The syringe filled with biolon and a ray croft needle was attached with lure lock.The clear attachment to the syringe revolved as the needle was being secured.The plastic round tip kept revolving and did not lock.The cannula detached itself during surgery, causing a tear to the anterial chamber.It was confirmed, that the hospital staff used the correct cannula provided with biolon.The cannula detachment during surgery, causing a tear to the anterial chamber was medically significant.Conclusion from complaint management report (qa track): root cause could not be concluded.Release of all affected batches.The complaint's investigation did not reveal any quality issue related to btg processes or raw materials.There are differences in the strengths of the connection of the luer lock (lla) to the barrel allowing a free rotation of the luer lock.This causes the doctor/nurse to believe that the cannula is not attached properly and further rotation of the cannula is required.Additional rotation of the cannula causes weakening of the cannula- barrel connection, which might result in detachment of the cannula during use.In order to enable proper assembly of the cannula and in order to prevent cannula detachment, it is mandatory to follow the instruction specified in the product leaflet and verify that the cannula is tightened to the barrel, meaning that the doctor / nurse must twist it to its position until it stops.If the lla doesn't stop, the doctor / nurse must hold the white lla in his / her fingers in one hand, while twisting the cannula base to its position until it stops in his / her second hand.In order to improve needle assembly to the syringe, btg produced detailed instruction videos in english which detail the correct assembly procedure of the needle into the syringe.Btg is convinced that this instruction movie will improve the needle assembly procedure by the physicians and will prevent similar complaints in the future.Action taken to biolon was unknown.At initial reporting time, the outcome of the tear to the anterial chamber was unknown.No concomitant medication was reported.Overall listedness (core label) is unlisted.Reporter causality: related; company causality: related.Other case numbers: internal # - affiliate = (b)(4).Internal # - complaint = (b)(4) and (b)(4).This ae occurred in united kingdom and concerns the medical device biolon.Please report to your local health authority if required by local law.This ae is reportable in eu because it meets the definition of a medical device incident according to the requirements of the medical device directive and occurred in a eu + efta country.No corrective action was done by the manufacturer or requested by regulators.Conclusion from complaint management report (qa track) received 07 nov 2019: updated narrative, added additinal qa track number (b)(4).

• Brand Name: BIOLON
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• MDR Report Key: 9162895
• MDR Text Key: 168570996
• Report Number: 3000164186-2019-00043
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: P14511CA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR