MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; SYRINGE, PISTON

Catalog Number 302995

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 01/25/2022

Event Type  malfunction  

Event Description

During an iv blood draw the inside of the 10ml syringe broke off into the iv set where blood was being drawn from.The patient was not harmed but had to have another iv insertion.The inside plastic tip of the 10ml syringe broke off into one of the yellow dual ports of the iv catheter.

• Brand Name: N/A
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 13548577
• MDR Text Key: 285741150
• Report Number: 13548577
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022,01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302995
• Device Lot Number: 1279491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female