MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. BIOLON; PRE FILLED SYRINGE

Lot Number U17147CA

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

All the syringes inside the box are not sealed so it seems not sterile [product sterility issue] case narrative: case (b)(4) is a serious spontaneous case originated from a technical complaint received from a wholesaler at the palestinian authority (jordan).Report received via technical complaint on biolon 10 mg/ml, prefilled syringe, solution for injection where all the syringes inside the box are not sealed so it seems not sterile.It was reported on a unspecified date that all the syringes inside of a biolon 10 mg/ml solution for injection syringe box were not sealed so it seems not sterile.The lot number was reported as u17147ca and the expiration date was reported as oct-2025.Event of 'product sterility issue' was considered to be serious and reportable due to the potential to might lead to any serious incident.Action taken with biolon was not applicable.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comment: no patient/user was involved nor exposed, case captured and reportable due to potential might lead to any serious incident.This complaint is linked to 'bio-contamination' hazard which is linked to 'results in injury or impairment requiring professional medical intervention' harm, ranked as s3 (safety) 'systemic infection requiring professional medical intervention".Overall listedness (core label) is listed.Reporter causality: related; company causality: related; other case numbers: internal # - complaint = (b)(4).This ae occurred in israel 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) 2017/745 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.Case correction 05-oct-2023: country of case has been corrected from israel to jordan and the device type has been added in the product information tab.Case correction 10-oct-2023: one more seriousness criteria of intervention required has been added.Case correction 11-oct-2023: occupation from the reporter information has been removed.

• Brand Name: BIOLON
• Type of Device: PRE FILLED SYRINGE
• 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: 17918898
• MDR Text Key: 325452034
• Report Number: 3000164186-2023-00055
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: GZ
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: U17147CA
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other