MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA; SYRINGE, PISTON

Model Number	329461
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Account - mayo clinic.Material description - syringe 0.5ml 28ga 1/2in bls 500cas ca.Material# - 329461.Material lot# - unknown.Complaint - duplicate uou gtin.The information provided shows that embecta material number 329461 has the same device id unit of use number like bd vacutainer material number 367391.Hi xxx, it has been a while since we last spoke, i hope you are doing well.I recently joined the mayo clinic team (previously (b)(6)) and was not able to attend the last htg meeting you presented at.Xxx and xxx shared the slides with me to bring me up to speed (very informative great slide deck).I am working on data corrections within our pim and came across the below.Could you please help me understand the duplicate uou gtin, or provide a good contact for me to work with on these sorts of issues ? thanks in advance!.
Additional Manufacturer Narrative
H3 other text : device not available.
Additional Manufacturer Narrative
Correction to h6 (component code, type of investigation, investigation conclusions) investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18938309
• Report Number: 1920898-2024-05063
• Device Sequence Number: 7042534
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: Lay User/Patient
• Device Model Number: 329461
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown