MAUDE Adverse Event Report: HOSPIRA, INC. HYDROMORPHONE HCI CARPUJECT INJECTOR ; ADAPTOR, HOLDER, SYRINGE

Lot Number 10760LL

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2020

Event Type  malfunction  

Event Description

Carpuject broke off during injection.Diagnosis for use: pain.

• Brand Name: HYDROMORPHONE HCI CARPUJECT INJECTOR
• Type of Device: ADAPTOR, HOLDER, SYRINGE
• Manufacturer (Section D): HOSPIRA, INC.
• MDR Report Key: 9865094
• MDR Text Key: 184665791
• Report Number: MW5093864
• Device Sequence Number: 1
• Product Code: IQG
• UDI-Device Identifier: 0409128303
• UDI-Public: 0409-1283-03
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2021
• Device Lot Number: 10760LL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR