MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL NEXT GEN 5.4QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305517
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed in as flextronics is an oem manufacturing site.Device expiration date: unknown.Device manufacture date: unknown.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 the bd sharps coll next gen 5.4qt red has missing label.The following information was provided by the initial reporter: according to the customer's report, when taking the product out of the carton, the hcp found that the label was missing.
Additional Manufacturer Narrative
H6: investigation summary : according with the pictures received showing the lack of label in the base and the issue description where it¿s mentioned that when taking the product out of the carton, the hcp found that the label was missing, we can identify this issue as a failure mode related to the manufacturing process.A device history review could not be completed as no batch number was provided.
Event or Problem Description
It was reported that the bd sharps coll next gen 5.4qt red has missing label.The following information was provided by the initial reporter: according to the customer's report, when taking the product out of the carton, the hcp found that the label was missing.

• Brand Name: BD SHARPS COLL NEXT GEN 5.4QT RED
• 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: 15195755
• Report Number: 2243072-2022-01281
• Device Sequence Number: 6014153
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: 00382903055173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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 Model Number: 305517
• Device Catalogue Number: 305517
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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