MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTI-USE ONE-PIECE SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305488
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is oem - (b)(4).This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: na.Investigation summary: no product or photo was returned by the customer.The customer reported that they closed the lid of sharps container and could not re-open it could not be verified due to the product not being returned for failure investigation.Device history record review for material # 305488 and lot number 2096001 was performed by supplier and dhr reference supplier's attached roi in investigation overview tab.A review of the ncr was performed.Non-conformity: customer stated that when they closed the lid, it would not open.But as per the requirements if lid is in the closed position, it should be able to reopen.If lid is in final closure position and tab is locked, it should stay closed disposition rationale is no product in stock.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However, potential root cause is as there is not enough information from customer to determine if cap lid was in locked position or not.When lid is in this position, it should not reopen.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that the bd¿ multi-use one-piece sharps collector lid was broken.The following information was provided by the initial reporter: consumer called to report that she closed the lid of her sharps container and could not re-open it.

• Brand Name: BD¿ MULTI-USE ONE-PIECE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15136159
• Report Number: 2243072-2022-01031
• Device Sequence Number: 17445170
• Product Code: FMI
• UDI-Device Identifier: 00382903054886
• UDI-Public: 00382903054886
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: Lay User/Patient
• Device Model Number: 305488
• Device Catalogue Number: 305488
• Device Lot Number: 2096001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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