MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SHARPS DISPOSAL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd sharps disposal was missing lids.The following information was received by the initial reporter with the verbatim: verbatim: rcc received a complaint via email.Email(s) attached.Reported issue: missing lids.Injuries or adverse event: no.Item: 305517.Quantity affected: 6 each.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: 6 sharps containers were received without lids.This verified the customer's complaint.The supplier of the lids was contacted and due to their advanced weighing system- it is near impossible for product to be shipped without lids.The root cause of this issue is unknown but most probable root cause is distributor handling issues.A review of the ncmr¿s was performed; the result showed no issues reported for missing lids for the same part number throughout the last twelve months.
Event or Problem Description
Samples received.

• Brand Name: BD SHARPS DISPOSAL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18207857
• Report Number: 2243072-2023-02091
• Device Sequence Number: 6247537
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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 Catalogue Number: 305517
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 11/26/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown