MAUDE Adverse Event Report: VIAL; LUBRICANT, PATIENT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

In xxxxx of 2022, a finding was reported by an administrator of the family birth center here at xxxxxxx medical center of xxxxxxxx, xxxxxxxxx.The potential medication error that was involved is the "muri-lube" mineral oil 2ml vials, which are not for parenteral use.These vials are quite similar in appearance in regards to shape and size to injectable vials of diphenhydramine, hydralazine, fentanyl, atropine and more.Although the color of the safety dust caps are distinguishable, it is not enough to mitigate the risk of its improper use.The appearance of these vials could have easily been mistaken for iv fentanyl or lidocaine and possibly been intravenously administered.Swiftly, a meeting was held with the leaders of the hospital from the departments of pharmacy, anesthesia, supply chain, and quality assurance.The in patient pharmacy and anesthesia departments identified all locations of fiberoptic carts i the medical center and performed a sweep to remove all the vials and replace them with a more distinguishable product, 30ml mineral oil cups manufactured by mckesson.Furthermore, a flyer titled "practice alert: mineral oil fiber optics cart" was created to elucidate the look-alike-sound-alike (lasa) risk that was posed by the previous formulation and placed throughout anesthesia units, family birth centers, and throughout other units that utilize mineral oil.This finding, when communicated wit other xxxxxxxxxxx medical facilities, received much recognition in mitigating risk and ensuring patient safety.(b)(4).

Event Description

Additional information received for report mw511207 on 11/8/2022 to update procode.

• Brand Name: VIAL
• Type of Device: LUBRICANT, PATIENT
• MDR Report Key: 15428502
• MDR Text Key: 300233964
• Report Number: MW5112070
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2022
• Patient Sequence Number: 1
• Treatment: MURI-LUBE/OIL/VIAL/10ML