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

Catalog Number 305093

Device Problem Break (1069)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: na.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 and the franklin lakes fda registration number has been used for the manufacture report number.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Address information was not able to be obtained, therefore, nj was used as a place holder.

Event Description

It was reported that the bd recykleen¿ foot operated trolley was damaged and the lid does not shut all the way.The following information was provided by the initial reporter: having issue when you step on the foot pedal the actual piece does not shut the lid all the way causing a hospital staff to have risk of dirty needle sticks and no compliance.

Manufacturer Narrative

(b)(4) ¿ follow up mdr for device evaluation.No product was returned by the customer.Video representation was provided for the complaint.According to video was received as evidence of the issue reported, where it can be seen that once user press the foot pedal, lid opens as intended, however, does not come back to the original position.According to the dhr review process, the result showed there were no issues reported like trolley defective during the manufacturing process for the lot number (3027933) reported under this complaint.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.Investigation: based on the video and information provided, it can be mentioned the following: ¿ the foot pedal does not work correctly causing the lid to not return to the closed position.¿ within global complaint detail report, it¿s mentioned that customer was having issue when they stepped on the foot pedal, the actual piece does not shut the lid all the way causing a hospital staff to have risk of dirty needle sticks.It can be noticed that this is a known failure mode (failure/damaged wire) since it has been reported in previous complaints.This failure mode was confirmed like a failure in a component (foot pedal mechanism) bought to a supplier, for this reason a capa records were opened to implement corrective actions that helps to decrease or avoid recurrences.Based on the lot number provided, it¿s possible to confirm that this product was manufactured in february 2023 which means that this was manufactured after corrective actions¿ implementation, because of this, the current raw material (mechanism) was verified to confirm if rivets are being received with correct crimping.This verification showed that cable have variation on the crimping force (this was verified trough a functional pull-test).For this reason, improvements have been made to reinforce the mechanism (wire) crimping within our process by adding the process to crimp the wire when the rivet has no crimp marks.In addition, a notification will be issued to suppliers to inform them of this raw material issue.As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, no additional complaints were received throughout the last twelve months for the same lot number and issue.However, in previous complaints reporting same issue from the same family, it was concluded that the failure mode is related to the manufacturing process, and it was confirmed that after the implementation there were no complaints reported for the same issue.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: ¿ the lack of crimping in the cable.¿ end user misuse (the end user didn¿t follow the steps stated in the bd sharps collector ifu).Conclusion: based on this investigation, this 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 supplier to prevent this issue, this improvement actions were documented under capa record.Full implementation of corrective actions was completed since august 2019 and march 2020 as effective, however, with lot number provided we are able to confirm that product reported was manufactured after these implementations, for this reason, there has been improvements to reinforce the crimping of the mechanism (cable) within our process by adding the process to crimp the cable when the rivet has no marks of crimping.In addition, a supplier notification will be emitted to aware them about this issue on the raw material.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information.

• Brand Name: BD RECYKLEEN¿ FOOT OPERATED TROLLEY
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16803294
• MDR Text Key: 313912838
• Report Number: 2243072-2023-00661
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: 3027933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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