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

Catalog Number	305604
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd sharps disposal lid was difficult to close the following information was received by the initial reporter with the following verbatim: the sharps collectors will not close correctly which is a safety hazard.Our infusion nurses are reporting that it is much more difficult to close/secure the lids of the yellow bins, compared to before.They have to snap them on, and they are reporting it is harder to do.Evs picks these bins up, when they are ¾ full, in the end of the day, and we had at least one instance, when the bin¿s lid was not fully secured, and the trace chemotherapy spilled out.So there are potential ergonomics issues, and safety issue for both infusion and evs team.Product#: 305604.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Samples received.
Additional Manufacturer Narrative
Investigation summary: one sample was received and investigated by our quality team.The lid on container would not shut as customer complaint mentioned and the complaint has been verified.The supplier was contacted for possible root cause and the determined issue was most likely due to incorrect gasket dimensions(thickness) during production.Device history record review to verify if during the manufacturing process there were issues reported for lid will not shut for lot 4030953 manufactured on 02/03/2024 and lot 4030941 manufactured on 02/01/2024, which had no issues found.A review of the ncmr¿s was performed; the results exhibit no issue 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: 18976667
• Report Number: 2243072-2024-00444
• Device Sequence Number: 12332139
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: (01)00382903056040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 09/25/2024

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: 305604
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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