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

Catalog Number 305091

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: according with this investigation and the information provided from the customer report, where it describes that the wire connecting between cart and slide, which is usually hard to break, was damaged.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 (yang ju industries corp), for this reason a capa records were opened (b)(4) to implement corrective actions that helps to decrease or avoid recurrences.Since no lot number was provided, it can¿t be confirmed if this product was manufactured before or after the corrective actions¿ implementation.As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, nine additional complaints were received throughout the last twelve months for the same part number and issue.In the previous complaints it was concluded that the failure mode is related to the manufacturing and it was confirmed that after the implementation there were no complaints reported for the same issue.

Event Description

It was reported that the wire connecting the slide of the bd recykleen¿ foot-operated trolley sharps collector to the cart was damaged.The following information was provided by the initial reporter, translated from japanese: "this is a report about a damaged wire of sharps collector.According to the customer's verbatim report, the wire connecting between the cart and slide, which is usually hard to break, was damaged.".

• 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: 14957007
• MDR Text Key: 304015204
• Report Number: 2243072-2022-00911
• 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
• Report Date: 06/24/2022

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: 305091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/08/2022
• 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