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

Catalog Number 6301182010

Device Problem Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Cap broke off between the leur lock [device breakage].Case narrative: this is a serious complaint spontaneous case received from a health professional in united states.This report concerns a patient (no patient identifiers reported) whose cap broke off between the luer lock during treatment with unknown euflexxa (sodium hyaluronate) solution for injection unknown concentration, 2ml, unknown route and frequency for an unknown indication from an unknown start date to an unknown stop date.On an unknown date, it was reported that the cap of the device (euflexxa) broke off between the luer lock, and the box was not damaged or wet.It was reported that the blister tray was sealed, the product was not used by the complainant, and it was available for return.The lot number was reported as v16305e and expiration date was reported as 17-mar-2025.The cap broke off between the leur lock was considered to be medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is listed.Reporter causality: related, company causality: related.Other case numbers: internal # - complaint = (b)(4).Internal # - other = (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) (b)(4) and/or because it did not occur in an eu + efta country + tr and ni and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.Correction 19-mar-2024: the occupation in reporter tab has been updated from healthcare professional to other healthcare professional.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 18951117
• MDR Text Key: 338258178
• Report Number: 3000164186-2024-00017
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Device Lot Number: V16305E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other