MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ RCRA HAZARDOUS WASTE COLLECTOR; SHARPS CONTAINER

Catalog Number 305072

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

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: na.The customer's address is unknown.Usa has been used as a placeholder based on the initial reporter facility name headquarters location.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd recykleen¿ rcra hazardous waste collector was cracked.The following information was provided by the initial reporter: "there is damage on every shipment".

Event Description

It was reported that the bd recykleen¿ rcra hazardous waste collector was cracked.The following information was provided by the initial reporter: "there is damage on every shipment.".

Manufacturer Narrative

H6: investigation summary: photos were received of the broken bases and the customer's complaint has been verified.The issue and evidence was then forwarded to the supplier for further investigation.The dhr review was not performed due to the lot number was not provided by customer.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid and base broken for the same part number throughout the last twelve months.The potential root causes were all related to secondary handling by different distributors before reaching end user.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 RECYKLEEN¿ RCRA HAZARDOUS WASTE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12957462
• MDR Text Key: 286356183
• Report Number: 2243072-2021-02874
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 305072
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1