MAUDE Adverse Event Report: HOSPIRA, INC. PREFILLED SYRINGE WITH LUER LOCK 0.5 ML

Lot Number 46540LL

Device Problems Failure to Advance (2524); Physical Resistance (2578)

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

Event Date 02/13/2015

Event Type  malfunction  

Event Description

Involves a pre-filled syringe with the following product info.Medication: hydromorphone hcl 0.5 mg/0.5 ml, 0.5 ml pre-filled syringe with luer lock.Mfr: hospira, inc., ndc # (b)(4), lot # 46540ll.Expiration date: october 10, 2016.While attempting to administer this medicine the plunger would not advance.There was extreme resistance at the plunger making the administration of this narcotic medication unsafe as it would require an extremely forceful "push" which would deliver the entire dose instantaneously.Pharmacist was called to bedside and allowed to witness this incident.Dates of use: (b)(6) 2015.

• Brand Name: PREFILLED SYRINGE WITH LUER LOCK 0.5 ML
• Type of Device: SYRINGE
• Manufacturer (Section D): HOSPIRA, INC.
• MDR Report Key: 4546530
• MDR Text Key: 15243716
• Report Number: MW5040905
• Device Sequence Number: 1
• Product Code: FMF
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2016
• Device Lot Number: 46540LL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1