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

Catalog Number 305093

Device Problem Defective Component (2292)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Device evaluated by mfr: 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 the bd recykleen¿ foot-operated trolley sharps collector lid would not properly open due to a defective/damaged latch.The following information was provided by the initial reporter, translated from japanese: "the customer's report is that the lid did not open properly possibly due to a damaged/defective wire.".

Manufacturer Narrative

H6: investigation summary 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 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.Based on the pictures provided and information from the customer describing that the lid did not open properly possibly due to a damaged / defective wire, it can be noticed that this is a known failure mode (loose 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 ((b)(4)), 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 on february 6, 2019, which means that this was manufactured before corrective actions¿ implementation.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 part 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.Root cause: the lack of crimping in the cable.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).

Event Description

It was reported that the bd recykleen¿ foot-operated trolley sharps collector lid would not properly open due to a defective/damaged latch.The following information was provided by the initial reporter, translated from japanese: "the customer's report is that the lid did not open properly possibly due to a damaged/defective wire.".

• 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 ; 8015296192
• MDR Report Key: 16279438
• MDR Text Key: 308613602
• Report Number: 2243072-2023-00105
• 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,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: 9037931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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