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

Model Number 305487

Device Problem Material Perforation (2205)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/27/2023

Event Type  Injury  

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 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.".

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 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
• Type of Device: 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
• MDR Text Key: 313394491
• Report Number: 2243072-2023-00622
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903054879
• UDI-Public: 00382903054879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention