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

Catalog Number 305093

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported that the bd recykleen¿ foot-operated trolley sharps collector lid would not shut due to a loose wire on the cart.The following information was provided by the initial reporter, translated from japanese: "the loose wire of the cart is making it difficult to open the lid.".

Manufacturer Narrative

D.4.Medical device expiration date: na.H.6.Investigation summary: no sample received but photos and video representation was provided for the complaint.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 (9158901) 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 information and evidence 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 it was found no damages or visual abnormality in the trolley, however, when they checked the operation of the product using an unused collector box, they found the foot pedal did not return to the correct position and lid remained open after stepping on the pedal.With that description, 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 from the label on mechanism, it¿s possible to confirm that this product was manufactured in may 2019 which means that this was manufactured before corrective actions¿ implementation, however, based on recent complaints received, 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 be performed on basis of photo and video representation, and a root cause could be determined as potential root cause as below: 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).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 and 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 and with lot number provided, we are able to confirm that product reported was manufactured before these implementations, however, 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.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17052394
• MDR Text Key: 316883623
• Report Number: 2243072-2023-00944
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: 2032961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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