MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 7.6L YEL AU NON-VENTED CAP; SHARPS CONTAINER

Catalog Number 303506

Device Problems Device Damaged Prior to Use (2284); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the sharps coll 7.6l yel au non-vented cap experienced a broken/damaged lid and device damage/deformation while still considered operable.Product defects were noted prior to use.The following information was provided by the initial reporter: during demonstration of once the lid is locked its locked and tamper proof the lid came completely off.During installation of bd sharps collectors at singleton hospital for a trial i was conducting a demonstration of the sharp collector, assembly and closure i accidentally locked the lid shut.In demonstrating once the lid is closed it is locked and not using excessive force but some to demonstrate the lid is locked, the entire lid came off.

Event Description

It was reported that the sharps coll 7.6l yel au non-vented cap experienced a broken/damaged lid and device damage/deformation while still considered operable.Product defects were noted prior to use.The following information was provided by the initial reporter: during demonstration of once the lid is locked its locked and tamper proof the lid came completely off.During installation of bd sharps collectors at singleton hospital for a trial i was conducting a demonstration of the sharp collector, assembly and closure i accidentally locked the lid shut.In demonstrating once the lid is closed it is locked and not using excessive force but some to demonstrate the lid is locked, the entire lid came off.

Manufacturer Narrative

H6: investigation summary during installation of bd sharps collectors at singleton hospital for a trial being conducting a demonstration of the sharp collector, assembly, and closure the lid was accidentally locked shut.To show that once the lid is locked it cannot be opened in the demonstration the entire lid came off.A sample picture was provided for further investigation.An evaluation of the picture confirmed the container is separated from the collector and the lid appears to be locked as it is closed and upside down.A complaint history review was performed and there are two other reported complaints for this product for unrelated issues, both for missing lids.A dhr review was not possible as no current bd manufacturing supplier for this product was identified and we are not able to confirm the current manufacturing details for this product at this time.Should a supplier confirm the manufacturing an additional closure letter may be provided with any additional results of the investigation.Based on the reported failure mode, the most likely source for this complaint was a loose cap.The cap may not have been firmly attached and fully connected to the container lid, and therefore was easily removable.It is possible that the lid and collector assembly limits between the two components are outside of or at the outer limits of the products manufacturing specifications.It is also possible that the lid was not firmly affixed by the user and sequentially was inadvertently and easily removable.See h.10.

• Brand Name: SHARPS COLL 7.6L YEL AU NON-VENTED CAP
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10554626
• MDR Text Key: 208819927
• Report Number: 2243072-2020-01448
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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
• Device Operator: Other
• Device Catalogue Number: 303506
• Device Lot Number: 6J801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other