MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN SOLOMED SYRINGE; SYRINGE, PISTON

Catalog Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).: initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f26 ¿ no health consequences or impact device problem code: a0413 - material separation.

Event Description

The embulum that broke during a complicated drug application.

Event Description

No additional information received.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, the plunger is observed detached.Unable to confirm the incident how the packaging was opened which could affect the integrity of the plunger.Throughout the manufacturing process, force testing are conducted for each lot.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.It is also necessary to evaluate the use of the syringe by the client since the syringe's function involves breaking the plunger to prevent reuse.It is important to follow the instructions for use of this product.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: UNKNOWN SOLOMED SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba IL 81460 ; BR 81460
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18229411
• MDR Text Key: 329266519
• Report Number: 3003916417-2023-00332
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1