MAUDE Adverse Event Report: BECTON DICKINSON BD PRE-FILLED FLUSH SYRINGES; SALINE, VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

The patient has a right measured chest wall port and prior to intravenous infusion, when the nurse uses a prefilled flush syringe to perform a flush to retrieve blood, she pushes the mandrel and the piston separates from the housing, resulting in fluid spillage; replace the syringe with a new one and perform a flush for the patient.

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0504 - leak / splash.

• Brand Name: BD PRE-FILLED FLUSH SYRINGES
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18210321
• MDR Text Key: 329027346
• Report Number: 2243072-2023-02094
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2023

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1