MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305076
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that 18 bd sharps coll chemo 3gal yellow new cap had incorrect label information.The following information was provided by the initial reporter: they are supposed to be vendor number: 305076 3 gallon yellow, but they have vendor number: 305489 6.9 qt red.
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 by the customer that 18 bd sharps coll chemo 3gal yellow new cap had incorrect label information.The following information was provided by the initial reporter: they are supposed to be vendor number 305076 3 gallon yellow, but they have vendor number 305489 6.9 qt red.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03-nov-2022.H.6.Investigation summary: 18 samples were returned by the customer.It was reported by the customer that the product is supposed to be 305076 but they are labeled 305489 could be verified and observed that 18 parts of the 305076, 3 gallon sharps containers had the wrong product label on them (305489).All testing was within specification.Requirement(s): the correct product labels should be on the bottles with the correct product #.Investigation: (describe the root cause) an issue was detected in july 2022 where the wrong product labels had been applied to the product.This was due to the product labels being stored in close proximity to each other in the quality lab storage area.After the issue was rectified, the labels were separated by press in the area where they are stored.The problem was thought to have been fully contained.This is a bounding/containment issue.Corrective action: separation of labels in the storage area with proper signs for which press they go to.Preventive action: label verification ensures that when label rolls change, the quality inspector on shift confirms the label information is the same and accurate.Conclusion : this issue was a previously detected issue which was simply not bounded well enough.Ca/pa have already been implemented.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15749220
• Report Number: 2243072-2022-01899
• Device Sequence Number: 17693007
• Product Code: FMI
• UDI-Device Identifier: 00382903050765
• UDI-Public: 00382903050765
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/02/2022

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 Catalogue Number: 305076
• Device Lot Number: 2188001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown