MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY TB SYRINGE; SYRINGE, PISTON

Model Number REF305945

Device Problems Failure to Advance (2524); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2020

Event Type  malfunction  

Event Description

Rn verified right dose, route, time, and patient for morning enoxaparin dose with a second rn.Rn then injected the needle into patient's subcutaneous tissue, but when the plunger was pressed, the medication would not deliver (plunger would not advance).Rn immediately removed needle from patient, drew back air but was still unable to advance plunger, no matter how much force was used.Dose given to pharmacy for investigation, and pharmacy made new dose.Faulty syringe needles/ plungers have been verbally reported with other patient's enoxaparin doses, and rn reporting to bring attention to pharmacy.Patient was upset that she had to be poked a second time for second enoxaparin dose made.Fda safety report id # (b)(4).

• Brand Name: TB SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 10091588
• MDR Text Key: 192638076
• Report Number: MW5094675
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF305945
• Device Lot Number: 9345879K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 53