MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD MICRO-FINE¿+ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 329487

Device Problem Complete Blockage (1094)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

It was reported that the bd micro-fine¿+ pen needle was blocked and couldn't deliver insulin during use.The following information was provided by the initial reporter, translated from chinese: "the patient came to our hospital for treatment due to type ii diabetes.The doctor gave the patient regular insulin injections.On (b)(6) 2022, the nurse prepared for the patient to inject insulin before meals.When the disposable needle was installed and exhausted, it was found that the needle was blocked and could not be used.Immediately replaced with a new needle, the insulin injection was smooth, and no harm was caused to the patient.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr was reviewed and there were not any qns or other events that could be related to this complaint.Clog test was conducted on 7pcs retention samples no needle clog fail found.

Event Description

It was reported that the bd micro-fine¿+ pen needle was blocked and couldn't deliver insulin during use.The following information was provided by the initial reporter, translated from chinese: "the patient came to our hospital for treatment due to type ii diabetes.The doctor gave the patient regular insulin injections.On (b)(6) 2022, the nurse prepared for the patient to inject insulin before meals.When the disposable needle was installed and exhausted, it was found that the needle was blocked and could not be used.Immediately replaced with a new needle, the insulin injection was smooth, and no harm was caused to the patient.".

• Brand Name: BD MICRO-FINE¿+ PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16039913
• MDR Text Key: 308243761
• Report Number: 3014704491-2022-00702
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 329487
• Device Lot Number: 8335597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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