MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC PEDS PLUS / F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number	442194
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that there was a labeling issue with a bd bactec¿ peds plus¿ / f culture vials.A "false" label was applied to bottle over the expiration date.
Additional Manufacturer Narrative
H6: investigation summary: bd was unable to reproduce customer experience with bactec¿ product.Retention samples were visually inspected with satisfactory results.Batch history records review did not identify any evidence from which the customer submitted the complaint.Complaint is confirmed based on photos.A cross evaluation was performed with the media batch number and the barcode sequences numbers.No corrective actions were required.The product was counterfeited outside of bd cayey.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
Event or Problem Description
It was reported that there was a labeling issue with a bd bactec¿ peds plus¿ / f culture vials.A "false" label was applied to bottle over the expiration date.

• Brand Name: BD BACTEC PEDS PLUS / F CULTURE VIALS
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11318702
• Report Number: 3008352382-2021-00038
• Device Sequence Number: 3753862
• Product Code: MDB
• UDI-Device Identifier: 00382904421946
• UDI-Public: 00382904421946
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K954927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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 Expiration Date: 05/31/2021
• Device Model Number: 442194
• Device Catalogue Number: 442194
• Device Lot Number: 0191287
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1