MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL SENSI-DISC CEFOXITIN - 30 G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Model Number	231591
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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.
Event or Problem Description
It was reported that there was a mix of product bd bbl¿ sensi-disc¿ cefoxitin - 30 g, packaging is for part# 231591, however, the cartridges were part# 231590.Product was used, however, there was no report of patient impact.The following information was provided by the initial reporter: packaging with product 231591 - cartridges with 231590 inside; 5 x à 10 cartridges, product used.
Additional Manufacturer Narrative
Investigation summary: a complaint investigation for cefoxitin batch no.: 0029199 was performed on retention samples.Returned goods were not received.Catalog 231591 belongs to fox-30.The investigation required to perform visual inspection, and batch record review.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.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 there was a mix of product bd bbl¿ sensi-disc¿ cefoxitin - 30 ¿g, packaging is for part# 231591, however, the cartridges were part# 231590.Product was used, however, there was no report of patient impact.The following information was provided by the initial reporter: packaging with product 231591 - cartridges with 231590 inside; 5 x à 10 cartridges.Product used.

• Brand Name: BD BBL SENSI-DISC CEFOXITIN - 30 G
• Common Device Name: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12095126
• Report Number: 3008352382-2021-00170
• Device Sequence Number: 3926276
• Product Code: JTN
• UDI-Device Identifier: 30382902315910
• UDI-Public: 30382902315910
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: PREAMENDMENT
• 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): 09/02/2021

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: 08/31/2022
• Device Model Number: 231591
• Device Catalogue Number: 231591
• Device Lot Number: 0029199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1