MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ FOOT-OPERATED TROLLEY SHARPS COLLECTOR; SHARPS CONTAINER

Catalog Number 305093

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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¿ foot-operated trolley sharps collector cable broke from the foot-piece.The following information was provided by the initial reporter: "caller states he has a recykleen (305093) and the cable is broken away from the foot operating piece.".

Manufacturer Narrative

H6: investigation summary the customer provided a complaint of defective trolley.Based on this investigation, it was confirmed the root cause like a failure mode related to the manufacturing process because the issue was already known in the process due to a supplier issue detected within the manufacturing process (the crimping on the rivet of foot pedal mechanism it wasn¿t done correctly).Corrective actions were implemented by flex and yang ju industries corp supplier to prevent this issue.According to the dhr review process, the result showed there were no issues reported like trolley defective during the manufacturing process.A review of the ncmr¿s was performed; the result showed there were no issues reported like trolley defective for the same part number throughout the last twelve months.H3 other text : see h10.

Event Description

It was reported that the bd recykleen¿ foot-operated trolley sharps collector cable broke from the foot-piece.The following information was provided by the initial reporter: "caller states he has a recykleen ((b)(6)) and the cable is broken away from the foot operating piece.".

• Brand Name: BD RECYKLEEN¿ FOOT-OPERATED TROLLEY 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12447937
• MDR Text Key: 270603090
• Report Number: 2243072-2021-02269
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 305093
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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