MAUDE Adverse Event Report: BECTON DICKINSON BD CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305604
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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.(b)(4).
Event or Problem Description
It was reported that 10 bd¿ chemotherapy sharps collectors with slide top and gasket were received without lids.The following information was provided by the initial reporter: "customer received 10 chemo waste bins without lids.".
Additional Manufacturer Narrative
H6.Investigation: the actual product nor photo representation was provided.A review of the device history record (dhr) was not possible since a lot number could not be provided.Also, a review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, ¿missing lids¿.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the box by the weighing system is required along with evidence of the original packaging to identify or confirm this issue.The root cause is inconclusive.H3.Other text : see h10.
Event or Problem Description
It was reported that 10 bd¿ chemotherapy sharps collectors with slide top and gasket were received without lids.The following information was provided by the initial reporter: "customer received 10 chemo waste bins without lids.".

• Brand Name: BD CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11122148
• Report Number: 2243072-2021-00007
• Device Sequence Number: 3583689
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: 00382903056040
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Other
• Device Model Number: 305604
• Device Catalogue Number: 305604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1