MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL; CONTAINER, SHARPS

Catalog Number 303205

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/09/2024

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.Batch number [25271001] was not found for material number [303205].

Event Description

It was reported that bd sharps coll needle pierced its base.The following information was provided by the initial reporter: a staff member obtained a nsi from a needle which had protruded through the base of the container.

Manufacturer Narrative

Investigation summary: one photo was received and analyzed by our quality team.The photo shows a needle tip protruding from the base of sharps container.The supplier of this product have been notified of this instance and have furnished quality records showing no issues during the production of this batch.The root cause of this issue is possibly due to a weak spot in wall of collector base but to reiterate there were no abnormalities with this device lot (25171001) and the supplier has mentioned that another possibility be a dropping of full container leading to puncture.

Event Description

Photos received.

• Brand Name: BD SHARPS COLL
• 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: 18779510
• MDR Text Key: 337423468
• Report Number: 2243072-2024-00207
• 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,Followup
• Report Date: 07/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303205
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 07/17/2024
• Supplement Dates FDA Received: 08/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other