MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SHARPS COLL WALLMATE 5.4QT BEIGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305559
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2020
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: unknown, device manufacture date: unknown.(b)(4).Investigation summary: no samples or photos are available for evaluation.Lot information is also unavailable at this time.No device history review is able to be completed.As a result, a potential root cause is unable to be defined and no corrective actions are required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no samples or photos are available for evaluation.Lot information is also unavailable at this time.No device history review is able to be completed.As a result, a potential root cause is unable to be defined and no corrective actions are required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: a potential root cause is unable to be defined.Rationale: no corrective actions are required.
Event or Problem Description
It was reported that sharps coll wallmate 5.4 qt beige was damaged, but still operable.The following information was provided by the initial reporter: "it was reported that the stringe was damaged.Event description per attached email states: 35241, 19039, syr 10 ml l/l no repl, 305559, n/a, damaged, 1.We were notified about some complaints from a customer stating the following components are not meeting the specs.Photos were received as a sample and the reported issues have been confirmed.We want to ensure that you are aware of the issues and that we do require a capa that addresses the particulate issue.Additionally, investigation is required for the remaining critical defect modes (missing component, dirty, damaged and hair).

• Brand Name: SHARPS COLL WALLMATE 5.4QT BEIGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10430392
• Report Number: 1213809-2020-00561
• Device Sequence Number: 19722268
• Product Code: FMI
• UDI-Device Identifier: 30382903055594
• UDI-Public: 30382903055594
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K943141
• 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
• Report Date (Section B): 08/11/2020

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
• Operator of Device: Other
• Device Model Number: 305559
• Device Catalogue Number: 305559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/20/2020
• 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