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	05/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was a reported that the temporary lid opens over time.During use, the temporary lid once closed opens over time.
Event or Problem Description
Imdrf codes must be updated.
Additional Manufacturer Narrative
Investigation summary: no photo or sample was received for the customer's complaint of lid issues.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.A device history record review could not be performed because a lot number was not provided by the customer.

• 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: 22079596
• Report Number: 2243072-2025-00676
• Device Sequence Number: 8702209
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879
• 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): 06/12/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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