MAUDE Adverse Event Report: YPSOMED AG CLICKFINE AP 31GX5MM ASCENDIS 4'500ER; PEN NEEDLE

Model Number CLICKFINE AP 31GX5MM ASCENDIS 4'500ER

Device Problem Material Twisted/Bent (2981)

Event Date 12/19/2023

Event Type  Injury  

Event Description

An eap patient experienced a medical emergency and hospitalization over a weekend.The patient began to experience progressively worsening symptoms of hypocalcemia and proceeded to the emergency room where she was administered forteo (which she had previously been on via infusion pump).She was discharged feeling better the following day.The patient had been completely off forteo and is on 36 mcg/d transcon pth.She had been injecting without issues for two weeks until this event.She stated that she tried to administer two sequential injections, possibly from the same pen: after the first injection, the patient did not think the pen injected the full dose and blamed the needle.After the second injection, the patient received the drug but may also have not been a complete dose.The patient noted that after the shot, she found that the needle was bent.

Manufacturer Narrative

An eap patient experienced a medical emergency and hospitalization over a weekend.The patient began to experience progressively worsening symptoms of hypocalcemia and proceeded to the emergency room where she was administered forteo (which she had previously been on via infusion pump).She was discharged feeling better the following day.Review of manufacturing processes and records show no deviations for the main batch 221399.The angle from the cannula is 100% controlled before fitting of the inner protective cap.Siliconization of the front and back end has permeability checked 100% through air flow measurements of the flow stream.Nothing was detected in-process regarding blockage or narrowing of the path during the assembly process.Fluid was also able to be administered during the handling test.Performed on retained samples from the same batch no device problem can be found.

• Brand Name: CLICKFINE AP 31GX5MM ASCENDIS 4'500ER
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern 3401 ; SZ 3401
• Manufacturer (Section G): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern 3401 ; SZ 3401
• Manufacturer Contact: clarisa tate ; 23 n echo park ct; mountain house, CA 95391 ; 5105796072
• MDR Report Key: 18543459
• MDR Text Key: 333249385
• Report Number: 3002806818-2024-00006
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K171984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CLICKFINE AP 31GX5MM ASCENDIS 4'500ER
• Device Catalogue Number: 700014895
• Device Lot Number: 221399-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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): Hospitalization