MAUDE Adverse Event Report: BECTON DICKINSON 9 GAL BD RECYKLEEN¿ FOOT-OPERATED TROLLEY; UNKNOWN

Catalog Number 305091

Device Problem Break (1069)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.Initial reporter phone #: unknown.Pma/510(k)#: not a medical device.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 lid does not close with a 9 gal bd recykleen¿ foot-operated trolley.The following information was provided by the initial reporter, translated from (b)(6) to english: the temporary lid opened.It seems the hook is tight.

Manufacturer Narrative

Investigation summary: 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.The dhr review process was not able to be performed due to the lot number was unknown.Based on information provided was not possible determine the root cause like a failure mode related to the manufacturing process due to there was not enough evidence provided to perform and accurate investigation.

Event Description

It was reported that the lid does not close with a 9 gal bd recykleen¿ foot-operated trolley.The following information was provided by the initial reporter, translated from japanese to english: the temporary lid opened.It seems the hook is tight.

• Brand Name: 9 GAL BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
• Type of Device: UNKNOWN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9197738
• MDR Text Key: 176052304
• Report Number: 2243072-2019-02314
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305091
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other