MAUDE Adverse Event Report: BECTON DICKINSON 19 GAL BD RECYKLEEN¿ FOOT-OPERATED TROLLEY; SHARPS DISPOSAL

Catalog Number 305093

Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

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 (b)(4) has been listed, and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 19 gal bd recykleen¿ foot-operated trolley lid is difficult to open.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the wire is loosened and the lid is hard to open.

Manufacturer Narrative

Investigation: no samples or pictures were received.Additional attempts to get more information or pictures were made, however in none of the cases additional information were provided.Dhr review process was not performed since the lot number was unknown.Based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process since there is not enough information related to this failure mode.A capa record was opened due to occurrences (high risk assessment result), this corrective action has been opened to perform an exhaustive investigation in order to rule out that some condition could contribute to a malfunction into the trolley assembly (capa record opened car-jrz-00000109).

Event Description

It was reported that 19 gal bd recykleen¿ foot-operated trolley lid is difficult to open.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the wire is loosened and the lid is hard to open.

• Brand Name: 19 GAL BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8556924
• MDR Text Key: 145777244
• Report Number: 2243072-2019-00804
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305093
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other