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 05/24/2023

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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that 10 bd recykleen¿ foot-operated trolley sharps collector had lids that do not close after release of the pedal.The following information was provided by the initial reporter: we are currently experiencing issues with the caddies for the 19-gallon sharps.The lid does not close after the release of the pedal.

Manufacturer Narrative

H6: investigation summary: the actual sample is unavailable for investigation.Photos are provided for verification.The device history record review process to verify is there were issues reported like trolley defective (lid will not shut) during the manufacturing process of this product was no able to be performed since no lot number was provided.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 pictures and information provided, it can be mentioned the following: ¿ within global complaint detail report, it¿s mentioned that the lid does not close after the release of the pedal and that two springs on the bottom of the units were broken causing the cable to rub on the plastic.¿ from the image 2, it¿s noticed that the plastic is damaged due to rubbing of the cable, however, this condition does not affect the functionality of the product.¿ customer reported damages on the springs, however based on image 3, no damages are observed.According with this investigation, this leads to user misuse of the product 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.As it can be seen in the photos, sample is in good conditions without any abnormality that could lead to malfunctions, for this reason, further investigation is not required.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 this investigation, a review of customer complaint records was performed; according with the cc¿s records, one additional complaint was received throughout the last twelve months for the part number and issue.This previous complaint was closed as incomplete since there was not enough information provided to determine the root cause.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: ¿ 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, it was not possible to determine the root cause of the issue reported since there was not enough information provided and with pictures received no damages were observed, for this reason, 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.If additional information that helps to find the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.H3 other text : see h10.

Event Description

It was reported that 10 bd recykleen¿ foot-operated trolley sharps collector had lids that do not close after release of the pedal.The following information was provided by the initial reporter: we are currently experiencing issues with the caddies for the 19-gallon sharps.The lid does not close after the release of the pedal.

• 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: 17139161
• MDR Text Key: 317463241
• Report Number: 2243072-2023-01027
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112774
• 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: 07/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2023
• 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