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

Model Number 231591

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event 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.

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 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
• Type of Device: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12095126
• MDR Text Key: 263554996
• Report Number: 3008352382-2021-00170
• Device Sequence Number: 1
• Product Code: JTN
• UDI-Device Identifier: 30382902315910
• UDI-Public: 30382902315910
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1