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

Catalog Number 231278

Device Problem Inaccurate Information (4051)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that prior to using bd bbl¿ sensi-disc¿ colistin - 10 g, five boxes arrived with incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer ordered bd 231278 disc colistin cl-10 however they received bd 230749 inside the box.Same lot number and expiry date however they have different bd item/sku number based on the box and its actual product inside.".

Event Description

It was reported that prior to using bd bbl¿ sensi-disc¿ colistin - 10 ¿g, five boxes arrived with incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer ordered bd 231278 disc colistin cl-10 however they received bd 230749 inside the box.Same lot number and expiry date however they have different bd item/sku number based on the box and its actual product inside.".

Manufacturer Narrative

H.6 investigation summary: a complaint investigation due to incorrect label for colistin catalog 231278 batch no.: 8426744 was performed on retention samples.The investigation required to perform visual inspection, batch record review and customer photo evaluation.No discrepancies observed during retention samples visual inspection.Photo received from customer was evaluated.It was observed that product was identified correctly.Single cartridge is identified with catalog 230749 while product package (ten pack) is identified with catalog 231278.Catalogs 230749 and 231278 are correct for colistin product.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.Complaint is not confirmed.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 h.10.

• Brand Name: BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17424585
• MDR Text Key: 320040312
• Report Number: 2647876-2023-00090
• Device Sequence Number: 1
• Product Code: JTN
• UDI-Device Identifier: 30382902312780
• UDI-Public: 30382902312780
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 231278
• Device Lot Number: 2210171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1