MAUDE Adverse Event Report: MORPHINE PCA MONOJECT SYRINGE; SYRINGE, PISTON

Device Problems Display or Visual Feedback Problem (1184); Defective Component (2292)

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

Event Type  No Answer Provided  

Event Description

With the national drug shortage crisis, healthcare providers are creating workarounds and encountering different looking products at a higher frequency.This latest error surprised me that no one noticed it until the occlusion alarm was triggered on the alaris pca pump.This morphine pca syringe made it passed the qa at the syringe manufacturer, passed the pharmacy technician that compounded a batch of morphine pcas, passed the pharmacist's that checked the final batch of pcas, passed the patient's nurse that hooked up the iv line to the pca syringe module.The defective empty syringe has been submitted to the fda.Medication administered to or used by the patient: yes; were other practitioner(s) involved (perpetuate) in the error: yes; nurse, pharmacist; error reached patient; no patient harm.(b)(6), access number: (b)(4).

• Brand Name: MORPHINE PCA MONOJECT SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 8197370
• MDR Text Key: 131766055
• Report Number: MW5082603
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1