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

Catalog Number 305328

Device Problem Defective Component (2292)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported that the bd recykleen¿ sharps collector lid would not open.The following information was provided by the initial reporter: "the top of the waste container will not open".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd recykleen¿ sharps collector lid would not open.The following information was provided by the initial reporter: "the top of the waste container will not open".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that the top of waste container will not open could not be verified due to the product not being returned for failure investigation.Dhr review process to verify if there were issues reported like lids closed during the manufacturing process was not able to be performed since no lot number was provided.A review of the ncmr¿s was performed; the result showed there were no issues reported for the same part number and issue throughout the last twelve months.

• Brand Name: BD RECYKLEEN¿ 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 ; 8448235433
• MDR Report Key: 16959305
• MDR Text Key: 315857117
• Report Number: 2243072-2023-00817
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903053285
• UDI-Public: 00382903053285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305328
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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