MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SHARPS COLL 8QT NEST FUNL TOP NEEDL PORT; SHARPS CONTAINER

Model Number	305344
Medical Device Problem Codes	Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a sharps coll 8qt nest funl top needl port was received two units with broken lids and two units with missing lids.The following information was provided by the initial reporter: reporting that he received sharp containers with broken lids (two of them) and another two were missing.
Additional Manufacturer Narrative
H.6.Investigation: no photo nor sample was provided for evaluation.The investigation could not confirm any issues related to manufacturing for the complaint.After follow up, the customer indicated, "the containers were shipped to us and received intact.The 2 lids were broken by us while being stored at the clinic and another 2 lids came up missing.The broken lids were discarded by staff when they were broken".The additional information indicated that the root cause for the complaint of missing and broken lids was most likely caused by the user facility.No manufacturing related issues were identified after a review of the processing controls for this product by the supplier.
Event or Problem Description
It was reported that a sharps coll 8qt nest funl top needl port was received two units with broken lids and two units with missing lids.The following information was provided by the initial reporter: reporting that he received sharp containers with broken lids (two of them) and another two were missing.

• Brand Name: SHARPS COLL 8QT NEST FUNL TOP NEEDL PORT
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10900901
• Report Number: 1911916-2020-01059
• Device Sequence Number: 16322626
• Product Code: FMI
• UDI-Device Identifier: 50382903053440
• UDI-Public: 50382903053440
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: Health Professional
• Device Model Number: 305344
• Device Catalogue Number: 305344
• Device Lot Number: 8310922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1