MAUDE Adverse Event Report: PHILLIPS MEDISIZE SYMJEPI; EPINEPHRINE INJECTION, USP

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 at 02:49 pm, an email was received by (b)(4) from the pharmacy director at (b)(6) hospital which stated, "issue we have had with the epi pen: the plunger to administer the medication has not worked twice, we have used three of the pen and only one worked thus far.Have you had issues (complaints) about the pen not working properly? we consider this a patient safety event." on 27/jul/2021 and 28/jul/2021, (b)(6) made several attempts at obtaining additional information from the reporter regarding the product complaint.On 28/jul/2021, (b)(4) forwarded the information regarding the product complain call to (b)(6) health.On 28/jul/2021, 29/jul/2021, 30/jul2021, and 02/aug/2021, (b)(6) health communicated with the pharmacy director, pharmacy manger, and er nurse supervisor at (b)(6) hospital via phone calls and emails.The following information were obtained: during the week prior to the initial contact date ((b)(6) 2021), 2 separate er rns reported having difficulties with the plungers of the symjepi product.During the first incident, the plunger did not work as it would not push forward.The rn obtained a second symjepi and had no issue.The rn was unable to confirm whether the second symjepi came from the same twin pack as the first unit.During the second incident, the same issue occurred with the plunger, the rn decided to use a vial of epinephrine instead, given the critical status of the patient.So, in this case the rn did not use a second symjepi.Both patients were experiencing anaphylaxis.No clinical sequelae were reported for either patient.No additional information could be provided regarding the patients.According to the er nurse supervisor, both rns have administered symjepi before, and have not encountered any issues with the plungers previously.According to the pharmacy manager, both symjepi with plunger issues were of the 0.3mg dosage form, and that they were "stored correctly".Since both symjepi products with plunger issues were discharged after usage, the lot numbers and expiration dates could not be obtained.As of 29/jul/2021, the lot number of the pharmacy's current 0.3mg dosage form inventory was 21041w (ndc # 7867013002).There were 3 twin packs left.The pharmacy manager could not confirm if the used products were from the same lot as they were both dispensed from the automated pyxis dispensing stations.As of 29/jul/2021, the pharmacy also had 3 twin packs of the 0.15mg dosage form left (lot # 21021y, ndc # 7867013102).As of 29/jul/2021, the pharmacy also had 3 twin packs of the 0.15mg dosage form left (lot # 21021y, ndc # 7867013102).Both the pharmacy manager and pharmacy director stated that they do not keep a list of all the lot numbers of symjepi shipped to their hospital pharmacy.According to the pharmacy manager, there was no formal training for the nurses on the administration of symjepi.When the new device came in, they worked with nurse education and the staff in the er to develop a "how to administer".A laminated copy of it is kept in the med room for the nurses to refer to.

• Brand Name: SYMJEPI
• Type of Device: EPINEPHRINE INJECTION, USP
• Manufacturer (Section D): PHILLIPS MEDISIZE; 428 technology drive east; menomonie WI 54751
• MDR Report Key: 12380076
• MDR Text Key: 283097814
• Report Number: 3002919960-2021-00002
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening