MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305435
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(6) has been listed.As flextronics is an oem manufacturing site.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.
Event or Problem Description
It was reported that the lids are missing with 15 bd sharps collector.The following information was provided by the initial reporter: it was reported by the sales representative that the lids are missing.
Additional Manufacturer Narrative
Investigation summary: no photo or sample was received with the customer's complaint of missing lids.Without further information, the complaint cannot be verified and the root cause remains unknown.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
Event or Problem Description
It was reported that the lids are missing with 15 bd sharps collector.The following information was provided by the initial reporter: it was reported by the sales representative that the lids are missing.

• Brand Name: BD SHARPS COLLECTOR
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12197288
• Report Number: 2243072-2021-01925
• Device Sequence Number: 3397756
• Product Code: FMI
• UDI-Device Identifier: 00382903054350
• UDI-Public: 00382903054350
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/06/2021

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: 305435
• Device Catalogue Number: 305435
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1