MAUDE Adverse Event Report: BECTON DICKINSON PEN II MYLAN 3.0ML; PEN NEEDLE

Catalog Number 47314378

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the customer issued a complaint for dosing incomplete from pen detected during use of the product by the end-user.One (1) sample was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured and released according to applicable procedures and specifications.Initial evaluation revealed no visible damage to the pen.The pen was tested for volumetric dose accuracy per it1172.All doses were within specification, and the pen functioned as intended.An injection sequence was executed using a 29g x 12.7mm bd pen needle and cartridge.Investigation conclusion: based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.Root cause description: based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.Rationale: unconfirmed, no issue observed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.

Event Description

It was reported that two pen ii mylan 3.0ml experienced an inability to deliver medication during use.The customer reported, "apokyn pen issues: pen doesn't administer medication completely and has to be readministered.This has happened with two pens, request for pen replacement prescription through the hub and md office.She stated this is not the first time this has happened and that sometimes the pens become defective after 2-3 months, and other times after one dose.The current defective pen she has is about 1 week old.".

• Brand Name: PEN II MYLAN 3.0ML
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8457773
• MDR Text Key: 145249243
• Report Number: 2243072-2019-00578
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47314378
• Device Lot Number: 16218001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2016
• 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): Other