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

Catalog Number	305613
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
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 that five bd¿ chemotherapy sharps collectors were missing lids.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported that five lids were missing when received.Sample photo representation was provided for evaluation.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance reported for missing lids for the same part number.This lot was confirmed produced after implementation of corrective actions.A weight system that provides a weighted label for each final box before shipment has already been implemented for this product to ensure the correct quantity of pieces per box before shipping, and it was confirmed that this lot was manufactured after corrective action implementation.The photo of the weighted label was provided along with the original packaging however the weight record did not show a detection of any missing components and therefore did not reject this package for shipping.It was not possible to confirm this failure mode was related to the manufacturing process since the scale is validated and did not detect any lack of components.The root cause is unknown.Based on these findings, our investigation is inconclusive.Bd will continue to monitor for any trends.
Event or Problem Description
It was reported that five bd¿ chemotherapy sharps collectors were missing lids.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD¿ CHEMOTHERAPY SHARPS COLLECTOR
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8051842
• Report Number: 2243072-2018-01566
• Device Sequence Number: 11241499
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: D015165
• 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): 01/24/2019

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: 8165917
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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