MAUDE Adverse Event Report: HOSPIRA; SYRINGE, PISTON

Lot Number 09-099-R1

Device Problems Crack (1135); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  malfunction  

Event Description

Pca machine beeped syringe error- checked syringe and the glass was cracked.Syringe, tubing, and machine changed.

• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): HOSPIRA; 375 n. field dr; lake forest IL 60045
• MDR Report Key: 12445698
• MDR Text Key: 270549743
• Report Number: 12445698
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 09-099-R1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1