MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTI-USE NESTABLE GUARDIAN SHARPS COLLECTOR

Catalog Number	305465
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
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: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd¿ multi-use nestable guardian sharps collector.There was an issue with lid broken.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: photos of the product damaged were provided.According to the dhr review process; the result showed there were no issues reported like lids and containers broken issue during the manufacturing process of the lot number reported under this customer complaint.Investigation conclusion: according to the pictures received from customer several damages areas can be seen on the lids and bases, this kind of damage could be caused by incorrect handling, transit damages or damages at the time to upload/download the material with the lifter.For this reason a picture of original packaging is required to rule out that this material wasn¿t repackaged, sold by a distributor in which the handling and storage process is unknown.Root cause description: based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process since there was not enough information to perform an extensive investigation to find where this problem could occur.Rationale: a quality alert was posted in the manufacturing process to make aware all personnel about this issue.This complaint information was captured for tracking and trending purposes.If additional information that helps to find the root cause is provided, then anew complaint record will be open in the flex system to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.
Event or Problem Description
It was reported with the use of the bd¿ multi-use nestable guardian sharps collector there was an issue with lid broken.There was no report of injury or medical intervention.

• Brand Name: BD¿ MULTI-USE NESTABLE GUARDIAN SHARPS COLLECTOR
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8039965
• Report Number: 2243072-2018-01571
• Device Sequence Number: 19203675
• Product Code: FMI
• UDI-Device Identifier: 00382903054657
• UDI-Public: 00382903054657
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 305465
• Device Lot Number: 8070901
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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