MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL¿ NEXT GEN 5.4QT CLEAR 20/PACK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305551
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd sharps coll¿ next gen 5.4qt clear 20/pack there was no label or missing label information.The following information was provided by the initial reporter.The customer received a sharps container that did not have the label.".
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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.
Additional Manufacturer Narrative
Investigation summary : photos of the affected sample were received and the customer's complaint was verified as the containers clearly lacked labels.The evidence was forwarded to the supplier to determine possible causes of this issue.A dhr review could not be performed since lot number information was not received, the complaint information only contains the family product and item.A review of the ncmr¿s was performed; the result showed there was one event reported (ncmr-jrz-00002207) as missing label issue for the same part number throughout the last twelve months.However, suspect material involved in that event was contained at the manufacturing site.Root causes include: product label missing on base due to variation on spaces among labels.-there is no specification defined for this component.Workstation not suitable for to perform reprocess of bases (labels) -the workstation must be modified for a better reprocessing of the material to correct this issue the supplier has implemented changes to the work station to better spot containers without label in software and a method to attach labels if defective product is detected.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd sharps coll¿ next gen 5.4qt clear 20/pack there was no label or missing label information.The following information was provided by the initial reporter.The customer received a sharps container that did not have the label.".

• Brand Name: BD SHARPS COLL¿ NEXT GEN 5.4QT CLEAR 20/PACK
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12754595
• Report Number: 2243072-2021-02666
• Device Sequence Number: 17283280
• Product Code: FMI
• UDI-Device Identifier: 50382903055512
• UDI-Public: 50382903055512
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 01/24/2022

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: 305551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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