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

Catalog Number 305091

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).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.Device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a 9 gal bd recykleen¿ foot-operated trolley's cart wire was damaged.

Manufacturer Narrative

Investigation summary: no samples or pictures were received.Three attempts to get more information or pictures were made, however in none of the cases additional information were provided.Dhr/ncmr review dhr review process was not performed since the lot number was unknown.A review of the ncmr¿s was performed; the result showed there were no issues reported like trolley defective(damaged cart wire) for the same part number throughout the last twelve months.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, the current process controls were reviewed in order to rule out that this failure mode is being omitted during the manufacturing process, the result showed that this fail can be detected in the functional test.

Event Description

It was reported that a 9 gal bd recykleen¿ foot-operated trolley's cart wire was damaged.

• Brand Name: 9 GAL BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8130733
• MDR Text Key: 129340901
• Report Number: 2243072-2018-01712
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903050918
• UDI-Public: 382903050918
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other