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

Catalog Number 305093

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

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.D.4.Medical device expiration date: na.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with bd recykleen¿ foot-operated trolley sharps collector the lid would not close properly.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the cart did not close well.The cart opened when the pedal was pressed, but did not close properly when closing.

Event Description

It was reported that during use with bd recykleen¿ foot-operated trolley sharps collector the lid would not close properly.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the cart did not close well.The cart opened when the pedal was pressed, but did not close properly when closing.

Manufacturer Narrative

The following field is to be considered corrected on the initial report: g.6 type of report (manufacturers): initial note: "5 day" was mistakenly selected on the initial report.There is no risk of substantial harm to the public health.Device evaluation.H6: investigation summary: the actual sample is unavailable for investigation.The pictures and videos were received as part of the evidence of the issue reported.According to the device history record review process, the result showed there were no issues reported like trolley defective (lid will not shut) during the manufacturing process for the lot number (2119955) reported under this complaint.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.Investigation: based on the information provided, within global complaint detail report, the lot number provided it¿s confirmed as manufactured by flex on april 29, 2022.Additionally, it¿s mentioned that customer reported that the cart did not close well.The sliding door opened when the pedal was pressed but did not close properly when closing.According with this investigation and evidence received, in the videos of the trolley being tested, it can be seen that the sliding lid is not fully closing, this could potentially be caused due to wear on the mechanism or this could be also related to user misuse since previously it has been detected that if the 19-gallon waste container it¿s not properly installed in the trolley (wrong positioning of the trolley cover into the 19-gallon slide-top), it could affect the functionality by not sliding the lid correctly.However, physical sample reported under this complaint is needed in order to determine the root cause of the issue reported.Also, as part of the manufacturing process, the product includes an ifu (instruction for use) in each box which explains how to perform correctly the assembly of the components and how to use it properly.However, if the method established within the ifu is not followed as intended then it will not function correctly.As part of the investigation, a review of the customer complaint records was performed and the result showed that there are three additional complaints reported for the same part number and issue, these previous complaints were closed as incomplete since there was not enough information and no sample available.As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, three additional complaints were received throughout the last twelve months for the same part number and issue.These previous complaints were closed as incomplete since there was not enough information provided to determine the root cause.Due to no sample being received, an investigation could be performed on basis of photo representation, and a root cause could be determined as potential root cause as below: ¿ end user misuse (the end user didn¿t follow the steps stated in the bd sharps collector ifu).¿ trolley mechanism damaged.Conclusion: based on this investigation and with the collected information, it was possible to confirm that the sliding door was not fully closing back to its original position.This informed failure mode could be associated to user misuse or due to wear of the mechanism, however, physical sample is needed in order to make functional tests over the product and be able to determine the root cause.The controls were reviewed and confirmed as capable to detect irregularities over the product.H3 other text : see h10.

• Brand Name: BD RECYKLEEN¿ FOOT-OPERATED TROLLEY SHARPS COLLECTOR
• Type of Device: SHARPS CONTATINER
• 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: 17336993
• MDR Text Key: 319155252
• Report Number: 2243072-2023-01243
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112774
• 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,Followup
• Report Date: 08/09/2023

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: 2119955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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