MAUDE Adverse Event Report: TB 9623 SYRINGE 1ML 27G 1/2'' TB; SYRINGE, PISTON

Device Problem Break (1069)

Patient Problem Underdose (2542)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Per patient's mom, needle broke while medication was being drawn up; patient only received partial dose; she will call manufacture for replacement; sending 50mg vial so patient can get remainder of dose tomorrow.No further information known.Unknown if needle is on hand for return to the manufacturer, unknown if any side effects occurred, unknown lot/expiration information.Indication: extreme immaturity of newborn, gestational age (b)(6) completed weeks.Reported to (b)(6) by: patient/caregiver.

• Brand Name: TB 9623 SYRINGE 1ML 27G 1/2'' TB
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 11344888
• MDR Text Key: 232823541
• Report Number: MW5099478
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 11 MO