MAUDE Adverse Event Report: BECTON DICKINSON BD 3QT RED SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd 3qt red sharps collector the lid was damaged.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about a damaged lid.The customer reported that the lid did not shut and was detached.
Additional Manufacturer Narrative
The manufacturing location for this product is pps.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no sample or photos is available for investigation.This report is about a damaged lid.The customer reported that the lid did not shut and was detached.Customer did not supply a lot# to complete dhr review.No other tasks are required at this time.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported while using bd 3qt red sharps collector the lid was damaged.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about a damaged lid.The customer reported that the lid did not shut and was detached.

• Brand Name: BD 3QT RED SHARPS COLLECTOR
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17446896
• Report Number: 2243072-2023-01358
• Device Sequence Number: 17957117
• Product Code: FMI
• UDI-Device Identifier: 00382903054886
• UDI-Public: (01)00382903054886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 305488
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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