MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML L/L NO NEEDLE; SYRINGE, PISTON

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

Spontaneous call: patient reported that the 50 ml syringes do not properly connect with the luer lock on the cassette and if she doesn't hold the connection, the syringe comes loose and the diluent sprays all over, forcing her to waste a mix and start over again.It doesn't happen every time, but almost every time and usually with second 50 ml syringe.She thinks it might due to a pressure issue.Asked pt if she feels like this issue with the 50 ml syringes occurs with certain lot numbers and pt stated no, she doesn't think lot number matters.Asked if the syringes do not screw on tight even when she is not pushing the diluent into the cassette.Patient stated yes.Notified nursing supervisors to send nurse to help troubleshoot issue.No adverse event occurred.Device not available for return.No missed dose.No other information known.Did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? ongoing, sending nurse to help troubleshoot.Did the reported product fault occur while in use with a pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available to be returned for investigation? no; did we replace the device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE 50ML L/L NO NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12481493
• MDR Text Key: 272211013
• Report Number: MW5104010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2021

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Patient Sequence Number: 1