MAUDE Adverse Event Report: BECTON DICKINSON & CO. SYRINGE 50-60ML L/L NO NEEDLE; SYRINGE, PISTON

Device Problems Defective Device (2588); Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Event Description

Solicited: pt asked to receive a few extra of some supplies because she has received some defective items in recent shipments (syringes that have no writing/numbers on them so no way to measure what she is drawing up; cassettes and mini spikes / adapters that do not malfunction), setup second order for extra dme pt asked for to arrive same day as q-stylevial adapters missing from last week's order.No add'l adverse events or side effects were mentioned due to product issues.Lots and expiration dates are unk.Unk if pt still has products on hands.No further info was provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE 50-60ML L/L NO NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10748612
• MDR Text Key: 213875151
• Report Number: MW5097509
• Device Sequence Number: 3
• 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: 10/23/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1