MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD CALIBRATED DISPOSABLE INOCULATING LOOPS; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Catalog Number	220217
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is copan.This site is an oem manufacturing site.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.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 prior to using bd calibrated disposable inoculating loops that the case was labeled with the 10ul product information but packed with the 1ul product.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed, and the loop color corresponds to the customer ordered item.Therefore, the indicated failure mode for incorrect product label was observed.Additionally, retention samples were evaluated by visual examination and the issue of incorrect product label was not observed.Retention samples of the lots manufactured immediately prior and after batch 2301040 were inspected and no issues were observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of incorrect labeling.The reported defect occurred during the packaging process.All relevant personnel have been made aware of the complaint complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported prior to using bd calibrated disposable inoculating loops that the case was labeled with the 10ul product information but packed with the 1ul product.There was no health impact or consequence reported.

• Brand Name: BD CALIBRATED DISPOSABLE INOCULATING LOOPS
• Common Device Name: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20715472
• Report Number: 1119779-2024-00900
• Device Sequence Number: 9638435
• Product Code: LXG
• UDI-Device Identifier: 00382902202172
• UDI-Public: (01)00382902202172(11)230316(17)280229(10)2301040
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 220217
• Device Lot Number: 2301040
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2023
• 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