MAUDE Adverse Event Report: HOSPIRA EMPTY CONTAINER

Catalog Number LIST NO. 7951-23

Device Problem Material Separation (1562)

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

Event Date 02/08/2017

Event Type  malfunction  

Event Description

Hospira empty container, 100-ml capacity flexible iv bag, list no.7951-23.When entering the admixture port with syringe needle, the diaphragm separates partially or completely.

• Brand Name: EMPTY CONTAINER
• Type of Device: EMPTY CONTAINER
• Manufacturer (Section D): HOSPIRA; lake forest IL 60045
• MDR Report Key: 6321714
• MDR Text Key: 67268237
• Report Number: MW5067802
• Device Sequence Number: 1
• Product Code: KPE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: LIST NO. 7951-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1