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

Catalog Number 305091

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.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.Device manufacture date: unknown.

Event Description

It was reported that the bd recykleen¿ foot-operated sharps collector lid would not close after stepping off the pedal.The following information was provided by the initial reporter, translated from japanese: "the customer¿s verbatim report is that the lid did not shut even after the hcp stepped off the pedal.".

Event Description

It was reported that the bd recykleen¿ foot-operated sharps collector lid would not close after stepping off the pedal.The following information was provided by the initial reporter, translated from japanese: "the customer¿s verbatim report is that the lid did not shut even after the hcp stepped off the pedal.".

Manufacturer Narrative

Investigation summary no photos or samples were received.Dhr review process to verify if there were issues like trolley defective was unable to be performed since there was no lot number provided.According to this investigation and the information provided by the customer report, it is described that with the foot pedal, the lid did not close automatically, however, the customer confirmed that after using the product several times, the lid was able to close.Based on this information, it can be noted that this is a known failure mode (loose wire) as it was reported in previous complaints.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 yang ju industries corp supplier to prevent this issue.

• Brand Name: BD RECYKLEEN¿ FOOT-OPERATED 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: 16186142
• MDR Text Key: 309016798
• Report Number: 2243072-2022-02342
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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