MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ 3ML SYRINGE; PISTON SYRINGE

Catalog Number 302632

Device Problem Material Separation (1562)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event: unknown.The date received by manufacturer has been used for this field.H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 60 of the bd solomed¿ 3ml syringe's plunger's are falling out.The following was received from the initial reporter: the client reports that the problem occurs when aspirating the medicine, the plunger is disconnecting the syringe coupling is not connected which makes it impossible to aspirate the medicine.*what is the deviation found with the material? the customer informs that the problem occurs when aspirating the medication, the plunger is disconnecting the syringe coupling is not connected, which makes it impossible to aspirate the medication.

Event Description

It was reported that 60 of the bd solomed¿ 3ml syringe's plunger's are falling out.The following was received from the initial reporter: the client reports that the problem occurs when aspirating the medicine, the plunger is disconnecting the syringe coupling is not connected which makes it impossible to aspirate the medicine.*what is the deviation found with the material? the customer informs that the problem occurs when aspirating the medication, the plunger is disconnecting the syringe coupling is not connected, which makes it impossible to aspirate the medication.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.It is also necessary to evaluate the use of the syringe by the customer since it is foreseen in the function of the syringe the breakage of the plunger to prevent reuse.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.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD SOLOMED¿ 3ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17573725
• MDR Text Key: 322043634
• Report Number: 3003916417-2023-00237
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302632
• Device Lot Number: 2049648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1