MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 50-60ML L/L NO NEEDLE; SYRINGE, PISTON

Lot Number 0205733

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Spontaneous call: patient's mother, (b)(6), said that for last shipment she received 3 bad syringes that are broken and medicine leaks out.No missed doses or adverse effects reported as a result.Unknown if she still has defective syringes on hand for return.Lot number and expiration date were reported.No further information.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 AND COMPANY
• MDR Report Key: 11265541
• MDR Text Key: 230057512
• Report Number: MW5099132
• 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: 01/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0205733
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 18 YR