MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR 3.3 QT RED; SHARPS CONTAINER

Catalog Number	305488
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that bd¿ sharps collector 3.3 qt red had the white lid that was tilted and removed.
Event or Problem Description
It was reported that bd¿ sharps collector 3.3 qt red had the white lid that was tilted and removed.
Additional Manufacturer Narrative
Investigation summary: bd received a box and a lid.Some scars were found in both box and lid, but no obvious damage or deformation found.Non-conformity: cap was tilted and removed from bottle.Requirement(s): lid should be fully attached to bottle and not removed.Reviewed complaint / pictures with all personal also reviewed dhr.Product started up while reviewing complaint.Increased aql while running and all caps were fully attached to base.
Additional Manufacturer Narrative
Correction: in previously submitted mdr, sections was incorrectly referenced as the medical device expiration date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date.
Event or Problem Description
It was reported that bd¿ sharps collector 3.3 qt red had the white lid that was tilted and removed.

• Brand Name: BD¿ SHARPS COLLECTOR 3.3 QT RED
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8121357
• Report Number: 2243072-2018-01664
• Device Sequence Number: 19204174
• Product Code: FMI
• UDI-Device Identifier: 50382903054881
• UDI-Public: 50382903054881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2019

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 Catalogue Number: 305488
• Device Lot Number: 8075002
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 11/09/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/28/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other