MAUDE Adverse Event Report: BECTON DICKINSON BD RECYKLEEN¿ FOOT-OPERATED TROLLEY; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305093

Device Problem Break (1069)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported when using the bd recykleen¿ foot-operated trolley, the device experienced a sharps collector with a difficult to close (will not close) lid.The following information was provided by the initial reporter.The customer stated: it was reported: received this item and the department is saying that the foot operation is defective.Stating that when you press on it, it will open the lid but will not close the lid back.Verbatim: we have received a quality complaint on product sold to our customer.Please, respond accordingly with the rma number, if necessary, and the disposition of the customer's concern.Medline reference: (b)(4), item: 305093, quantity affected: 1 ea, serial/lot number: not provided, po #: (b)(4).Are any samples available for return? yes.Customer disposition request: replacement.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed and (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.(b)(4).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 when using the bd recykleen¿ foot-operated trolley, the device experienced a sharps collector with a difficult to close (will not close) lid.The following information was provided by the initial reporter.The customer stated: it was reported: received this item and the department is saying that the foot operation is defective.Stating that when you press on it, it will open the lid but will not close the lid back.Verbatim: we have received a quality complaint on product sold to our customer.Please, respond accordingly with the rma number, if necessary, and the disposition of the customer's concern.Medline reference: (b)(4), item: 305093, quantity affected: 1 ea, serial/lot number: not provided, po #: (b)(4).Are any samples available for return? yes.Customer disposition request: replacement.

Manufacturer Narrative

Investigation summary : two photos were provided by customer of the label on a defective trolley.The issue was forwarded to the supplier and an investigation was conducted.This is an issue that the supplier is aware of and it has a root cause of lack of crimping in the cable that causes the trolley not to function correctly.There are now changes in place that insure all cables are thoroughly inspected before shipped to customers.A review of the ncmr¿s for part number 305093 was performed; the result showed there were no issues reported like trolley defective throughout the last twelve months.H3 other text : see h10.

Event Description

It was reported when using the bd recykleen¿ foot-operated trolley, the device experienced a sharps collector with a difficult to close (will not close) lid.The following information was provided by the initial reporter.The customer stated: it was reported received this item and the department is saying that the foot operation is defective.Stating that when you press on it, it will open the lid but will not close the lid back.Verbatim: we have received a quality complaint on product sold to our customer.Please, respond accordingly with the rma number, if necessary, and the disposition of the customer's concern.Medline reference: (b)(4).Item: 305093.Quantity affected: 1 ea.Serial/lot number: not provided.Po #: 4514326911.Are any samples available for return? yes.Reported issue per customer: we received this item and the department is saying that the foot operation is defective.Stating that when you press on it, it will open the lid but will not close the lid back.Customer disposition request: replacement.

• Brand Name: BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 12965198
• MDR Text Key: 285985097
• Report Number: 2243072-2021-02884
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 305093
• Device Lot Number: 1136923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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