MAUDE Adverse Event Report: HOSPIRA, INC. 1 ML SINGLE-DOSE CARPUJECT; ADAPTOR, HOLDER, SYRINGE

Lot Number 37665CL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

Rn went to take off white/green cap of morphine.Morphine glass syringe shattered.Fda safety report id# (b)(4).

• Brand Name: 1 ML SINGLE-DOSE CARPUJECT
• Type of Device: ADAPTOR, HOLDER, SYRINGE
• Manufacturer (Section D): HOSPIRA, INC.
• MDR Report Key: 15638637
• MDR Text Key: 302245924
• Report Number: MW5112759
• Device Sequence Number: 1
• Product Code: IQG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Lot Number: 37665CL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MORPHINE SULFATE