MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 19GAL YELLOW; SHARPS COLLECTOR

Catalog Number	305613
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
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 4 sharps coll chemo 19gal yellow lids were found broken before use.The following information was provided by the initial reporter: "customer informed tm of broken lids on chemo bin 305613.".
Event or Problem Description
It was reported that 4 sharps coll chemo 19gal yellow lids were found broken before use.The following information was provided by the initial reporter: "customer informed tm of broken lids on chemo bin 305613.".
Additional Manufacturer Narrative
Investigation summary: a complaint review was performed by the supplier.Photos of the product damage were not provided and a lot number was not available.A review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to this reported incident for broken lids.A review of the current controls was completed, and a 100% visual inspection is performed by production along with a visual and functional inspection based on aql sampling plan is performed by a quality auditor.This type of damage could be caused by outer conditions such as a hard impact.It is possible that the damage occurred in transit during shipping or during the package handling.Bd will continue to monitor the complaint for any trends.

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8632478
• Report Number: 2243072-2019-00986
• Device Sequence Number: 2091008
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 06/27/2019

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: 305613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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