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

Catalog Number 323487

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 qe, a dhr review of the risk management file for this issue shows that the risk for this issue is low.Investigation conclusion bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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 a bd¿ sharps collector, the sharps container lid would not shut.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Reason code for no evaluation: other.

Event Description

It was reported that a bd¿ sharps collector, the sharps container lid would not shut.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTORS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8010335
• MDR Text Key: 125283270
• Report Number: 2243072-2018-01523
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (y/n): N
• PMA/PMN Number: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• 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: 8127001
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other