MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320881

Device Problem Misconnection (1399)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported that the outer cover of the bd ultra-fine¿ short pen needle would not attach to the pen after use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "stated, "the gray part will not stay on pen needle after use".Stated, she is not sure if her husband is referring to "needle shield or outer cover.When did the incident occur?: during use.Death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first aid: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.H3 other text : see h10.

Event Description

It was reported that the outer cover of the bd ultra-fine¿ short pen needle would not attach to the pen after use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "stated, "the gray part will not stay on pen needle after use" stated, she is not sure if her husband is referring to "needle shield or outter cover.When did the incident occur?: during use.Death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first aid: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no.".

• Brand Name: BD ULTRA-FINE¿ SHORT PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16703250
• MDR Text Key: 312913992
• Report Number: 9616656-2023-00332
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: Lay User/Patient
• Device Catalogue Number: 320881
• Device Lot Number: 1334605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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