MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NESTABLE SHARPS COLLECTOR; SHARPS CONTAINER

Model Number	305487
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the customer received a dirty needle stick injury from a used sharp protruding through the bd¿ nestable sharps collector wall when disposing of the container.The following information was provided by the initial reporter, translated from japanese: "the customer's verbatim report is as follows: the customer got injured with the needle tip coming out through the container when disposing the sharps collector after autoclave.".
Additional Manufacturer Narrative
H6: investigation summary no product was returned by the customer.Photos representation was provided for the complaint.A device history review could not be completed as no batch number was provided.Root cause: based on information provided by user (no physical samples), the root cause can¿t be determined, according to our process and non-conforming material system records, this kind of failure has not been detected on manufacturing process throughout last twelve months.Based on this investigation, there is not enough information provided from customer like a lot number or physical sample to determine the root cause of this issue, with available information.
Event or Problem Description
It was reported that the customer received a dirty needle stick injury from a used sharp protruding through the bd¿ nestable sharps collector wall when disposing of the container.The following information was provided by the initial reporter, translated from japanese: "the customer's verbatim report is as follows: the customer got injured with the needle tip coming out through the container when disposing the sharps collector after autoclave.".

• Brand Name: BD¿ NESTABLE SHARPS COLLECTOR
• Common Device Name: SHARPS CONTAINER
• 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 ; 8448235433
• MDR Report Key: 16747659
• Report Number: 2243072-2023-00622
• Device Sequence Number: 8555991
• Product Code: MMK
• UDI-Device Identifier: 00382903054879
• UDI-Public: 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
• 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): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305487
• Device Catalogue Number: 305487
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown