MAUDE Adverse Event Report: ICU MEDICAL / HOSPIRA HOSPIRA; PCA STERILE VIAL AND INJECTOR

Model Number	6021-03
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pca empty vial and pca vial cap contained visible particulate - a common problem we have noted in using the product for more than 6 months.

• Brand Name: HOSPIRA
• Common Device Name: PCA STERILE VIAL AND INJECTOR
• Manufacturer (Section D): ICU MEDICAL / HOSPIRA; lake forest IL 60045
• MDR Report Key: 7809459
• Report Number: MW5079345
• Device Sequence Number: 13943064
• Product Code: FMF
• UDI-Device Identifier: 10887787001904
• UDI-Public: 10887787001904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: 6021-03
• Device Catalogue Number: 6021-03
• Device Lot Number: 67053121
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1