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

Catalog Number 305093

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device expiration 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.Hdevice manufacture date: unknown.

Event Description

It was reported that the lid of the bd recykleen¿ foot-operated trolley was difficult to open and the cart wiring had gone slack.The following information was provided by the initial reporter, translated from (b)(6) to english: "the wire of the cart gone slack and the lid was hard to open.".

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.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 (wire gone slack) for the same part number throughout the last twelve months.According with this investigation there is no enough information available to perform an exhaustive investigation due to no samples or pictures were provided in this complaint, as part of this investigation it was reviewed the customer complaint records; according with the cc¿s records, three additional complaints were received throughout the last twelve months for the same part number and issue however, in none of the cases, evidence was received.Additionally, the complaint record says that the wire was damaged; however, more information is needed like how long the trolley has it been in use, the sample or lot number in order to rule out that the damage was caused due to normal use (long time in use (worn-out)).As part of the current manufacturing process controls, a 100% inspection is performed by production department on each trolley for all functional and visual characteristics; additionally, a second inspection is performed by quality inspector based on an aql sampling plan.Conclusion: 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 the lid of the bd recykleen¿ foot-operated trolley was difficult to open and the cart wiring had gone slack.The following information was provided by the initial reporter, translated from japanese to english: "the wire of the cart gone slack and the lid was hard to open.".

• Brand Name: 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: 8440953
• MDR Text Key: 139611771
• Report Number: 2243072-2019-00540
• Device Sequence Number: 0
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other