MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HOME SHARPS CONTAINER; SHARPS COLLECTOR

Catalog Number 323487

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.As per attached dhr, ¿no ncrs were raised during the production of this lot.All testing was within specification.¿ investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the lid on the bd¿ home sharps container "popped" open after disposing lancets and test strips in it.The following information was provided by the initial reporter: "places her lancets and test strips within container and lightly places lid on container with each use.Then places lid fully on container when disposing.Feels the lid is not sturdy or secure for disposal , it pops open.".

• Brand Name: BD¿ HOME SHARPS CONTAINER
• Type of Device: SHARPS COLLECTOR
• 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: 9166294
• MDR Text Key: 172686469
• Report Number: 2243072-2019-02228
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 323487
• Device Lot Number: 5361001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2006
• 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