MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. WHISPERJECT; INTRODUCER, SYRINGE NEEDLE

Lot Number BF21005297

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 10/09/2022

Event Type  malfunction  

Event Description

Narrative from staff: attempted to administer 38 units of insulin glargine, pen only dispensed 20 units, unable to administer remainder from this pen.Pharmacy notified; new pen dispensed.Discussed with md, remaining 18 units administered from new pen.

• Brand Name: WHISPERJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.; 3711 collins ferry road; morgantown WV 26505
• MDR Report Key: 15657338
• MDR Text Key: 302253145
• Report Number: 15657338
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: BF21005297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6570 DA
• Patient Sex: Female
• Patient Weight: 65 KG