MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS); SEE H.10

Catalog Number 220217

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

D.1 common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use (b)(6).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.H.3.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 when using the bd calibrated disposable inoculating loops, blue 10l (20x50 loops) there were 10 mislabeled boxes.There was no report of impact to the patient or user.

• Brand Name: BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS)
• Type of Device: SEE H.10
• 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: 18830128
• MDR Text Key: 337435449
• Report Number: 1119779-2024-00169
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00382902202172
• UDI-Public: (01)00382902202172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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
• Report Date: 02/09/2024

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
• Device Operator: Other
• Device Catalogue Number: 220217
• Device Lot Number: 2301040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1