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

Catalog Number 305072

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.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.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 bd recykleen¿ rcra hazardous waste collector lids were broken.No patient impact was mentioned.The following information was provided by the initial reporter: rcra disposal container came with broken lids.

Event Description

It was reported that bd recykleen¿ rcra hazardous waste collector lids were broken.No patient impact was mentioned.The following information was provided by the initial reporter: rcra disposal container came with broken lids.

Manufacturer Narrative

H6: investigation summary: no photo or sample was received in the customer's complaint of broken lid.Without further information like a physical sample, the complaint cannot be verified and the root cause remains unknown.According to the dhr review process, the result showed there were no issues reported like lid broken / damaged issue during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken/damaged for the same part number throughout the last twelve months.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13122485
• MDR Text Key: 285480751
• Report Number: 2243072-2021-03015
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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
• Date Manufacturer Received: 03/16/2022
• 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