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U.S. Department of Health and Human Services

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

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BECTON DICKINSON SYRINGE 50ML L/L NO NEEDLE SYRINGE, PISTON Back to Search Results
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.
 
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Brand NameSYRINGE 50ML L/L NO NEEDLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12481493
MDR Text Key272211013
Report NumberMW5104010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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