MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Catalog Number	231691
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 product insert for bd bbl¿ sensi-disc¿ piperacillin/tazobactam - 100/10 g contained incorrect breakpoint information for piperacillin/tazobactam.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: a complaint investigation due to breakpoints listed in the package insert (pi) for piperacillin/tazobactam catalog 231691 (batch number not received) are aligned with clsi m100:ed30 instead of the m100:ed33.The investigation required to evaluate product insert and information sent by customer.Information sent by customer (photo from product insert section and clsi information) were evaluated.It was identified that product insert required revision.Complaint is confirmed.As a corrective action product insert was submitted for revision.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
It was reported that the product insert for bd bbl¿ sensi-disc¿ piperacillin/tazobactam - 100/10 g contained incorrect breakpoint information for piperacillin/tazobactam.There was no report of patient impact.

• Brand Name: BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 ¿G
• Common Device Name: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19173661
• Report Number: 2647876-2024-00067
• Device Sequence Number: 7873907
• Product Code: JTN
• UDI-Device Identifier: 00382902316916
• UDI-Public: (01)00382902316916
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K940359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: Other
• Device Catalogue Number: 231691
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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