MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 1.5QT RED; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305487
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer report there are always some products whose lids open during use.They would like this to be improved.It is a continuous occurrence, so they would like comments on improvements or countermeasures.It is occurring in multiple lots, so they would like it improved.As it is still in use, they have declined to return the actual product.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Imdrf codes must be updated.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: SHARPS COLL 1.5QT RED
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21865286
• Report Number: 2243072-2025-00542
• Device Sequence Number: 4695549
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879(11)240829(10)4235939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Catalogue Number: 305487
• Device Lot Number: 4235939
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown