MAUDE Adverse Event Report: HOSPIRA MINIBORE PCA EXTENSION SET -67 I

Model Number 14277-28

Device Problems Failure to Prime (1492); Device Markings/Labelling Problem (2911); Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 09/11/2014

Event Type  Injury  

Event Description

Minibore pca extension set 67 inch.Hospira # (b)(4) was primed with morphine 1mg/ml from pcaide all the way to the option lock male adapter.The instructions are correct on the package to only prime to the y-site.There is no marking at the y-site to warn you that you have reached that point.Thus it easy prime past this point.On (b)(6), 2014, 15:30 stop at 16:25 minibore pca extension set 67 inch.Hospira (b)(4).

• Brand Name: MINIBORE PCA EXTENSION SET -67 I
• Type of Device: MINIBORE PCA EXTENSION SET -67 I
• Manufacturer (Section D): HOSPIRA; los angeles 90027
• MDR Report Key: 4284347
• MDR Text Key: 5227120
• Report Number: MW5039303
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 14277-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 MO
• Patient Weight: 5