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

Catalog Number	305551
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd sharps disposal lid did not fit.The following information was provided by the initial reporter with the verbatim: reported issue: the lids do not secure to the container as needed for use.
Event or Problem Description
Sample received.
Additional Manufacturer Narrative
Investigation summary: photos and samples were received with the customer's complaint of incorrect lids.The provided lids were not the correct material for the bases - verifying the complaint.The root cause has been determined to be an incorrect material assortment at the time of packing.There has been a quality alert initiated by the sharps container supplier to eliminate future occurrences of this failure.A device history record review process was made and the result showed there were no issues reported like incorrect lids during the manufacturing process of the lot number reported (3224924) under this complaint.A review of the ncmr¿s was performed; the result showed that non-conformances were reported for the same part number and issue throughout the last twelve months.

• 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: 17947073
• Report Number: 2243072-2023-01874
• Device Sequence Number: 20723144
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: (01)00382903055517
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 305551
• Device Lot Number: 3224924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown