MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 1.4L YELLOW TRAY SIZE; CONTAINER, SHARPS

Catalog Number 303205

Device Problem Break (1069)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd sharps coll 1.4l yellow tray size lid is damaged.The following information was provided by the initial reporter: i have type 2 diabetes and have just received my new bgl monitor and all the bits and pieces that go with it.Yesterday i purchased one of the above containers to dispense the used lancets into however the strap to the lid appears to have been attached with a twist, meaning that the strap will need to be twisted if i want to attach the lid securely.I haven¿t tried to do that yet because i only purchased it yesterday and am yet to use it.I did point out the fault when it was brought to the counter however the lady who served me said not to worry about it and just to just leave it open (!) which i thought was a bit strange not only because it is a sharps container and the whole idea is about safety but also because, prior to bringing this one to me from out the back, she had been suggesting that i could save myself some money and just use an empty milk bottle or some other container as long as it had a lid! i said no because somebody might throw the milk container out and i would prefer to have a dedicated sharps bin please! when i told her that i have 5 small grandchildren who come and go frequently, her solution was to leave it somewhere high! the problem with that is that i am, in fact, very short with advanced arthritis and am just as likely to tip a heap of lancets on top of my head and face in reaching and tilting to get it down! she didn¿t offer to swap it so i can only assume that the others that she brought out to put on a display shelf were the same.It looks to me as though the strap is already ¿stressed¿ at the bending/twisting point without having been used yet so i am not sure how long it will remain attached.

• Brand Name: BD SHARPS COLL 1.4L YELLOW TRAY SIZE
• Type of Device: CONTAINER, SHARPS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18861414
• MDR Text Key: 337302766
• Report Number: 2243072-2024-00260
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903032051
• UDI-Public: (01)00382903032051
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 303205
• Device Lot Number: 21330001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1