MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL SENSI-DISC OXACILLIN - 1 G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Model Number	231319
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ oxacillin - 1 g atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the customer would like to complain about batch: 0121991 of oxacillin 1 g cartridges.The oxacillin is resistant to streptococcus pneumoniae atcc 49619.Customer had another batch (0092546) there and this is sensitive.".
Additional Manufacturer Narrative
H6: investigation summary: a complaint investigation for oxacillin batch no.: 0121991 was performed on retention samples.Returned goods were not received from customer.The investigation required to perform bauer kirby test, visual inspection, and batch record review.Retention samples performed as expected.Refer to results below.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Photo received was evaluated.Customer claim could not be confirmed through photo evaluation.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.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ oxacillin - 1 g atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "the customer would like to complain about batch: 0121991 of oxacillin 1g cartridges.The oxacillin is resistant to streptococcus pneumoniae atcc 49619.[customer] had another batch (0092546) there and this is sensitive.".

• Brand Name: BD BBL SENSI-DISC OXACILLIN - 1 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: 12110530
• Report Number: 3008352382-2021-00173
• Device Sequence Number: 11705994
• Product Code: JTN
• UDI-Device Identifier: 30382902313190
• UDI-Public: 30382902313190
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 05/31/2022
• Device Model Number: 231319
• Device Catalogue Number: 231319
• Device Lot Number: 0121991
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1