MAUDE Adverse Event Report: HOSPIRA, INC. STERILE EMPTY VIAL AND INJECTOR, PCA CARTRIDGE; PUMP, INFUSION, PCA

Model Number 6021-03

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

Small metalic/reflective shard noted inside unused empty glass pca vial.Only the one vial noted from a batch of 500 used in our production.Vial has been quarantined for any further investigation.Dates of use: never used; diagnosis or reason for use: analgesia iv delivery.

• Brand Name: STERILE EMPTY VIAL AND INJECTOR, PCA CARTRIDGE
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): HOSPIRA, INC.
• MDR Report Key: 8038061
• MDR Text Key: 126297148
• Report Number: MW5081044
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 6021-03
• Device Catalogue Number: 6021-03
• Device Lot Number: 68-050-R1
• Was Device Available for Evaluation?: Yes
• 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