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

Catalog Number 300491

Device Problem Break (1069)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the lid of the bd¿ sharps collector was damaged.The following information was provided by the initial reporter: "spoilt cover lid for 1.4l sharp box".

Event Description

It was reported that the lid of the bd¿ sharps collector was damaged.The following information was provided by the initial reporter: "spoilt cover lid for 1.4l sharp box".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that spoilt cover lid for 1.4l sharp box could not be verified due to the product not being returned for failure investigation.According to device history record review no non confirming report were raised during the production of this lot.No ncr were raised during the production of this lot.All testing was within specification.Requirement(s): lid should not be split.Investigation: (describe the root cause) as no sample is available from the end user.Insufficient information received from customer.No investigation done.Corrective action: insufficient information provided but immediate action taken as notified to all personal of complaint.Preventive action: insufficient information provided.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD¿ SHARPS COLLECTOR
• Type of Device: SHARPS CONTAINER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15705340
• MDR Text Key: 307010706
• Report Number: 2243072-2022-01866
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903004911
• UDI-Public: (01)00382903004911
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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: Other
• Device Catalogue Number: 300491
• Device Lot Number: 1218001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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