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

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	09/25/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 220217 (loops inoculating 50/tube 10 microliter), lot number 2301040, where it was observed that the box was mislabeled.Event description: "customer reporting mislabeled box of blue 10 ul loops 220217 lot 2301040." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not indicate any manufacturing issues.Sample analysis: the complaint notes indicate that returns were sent and received by bd.However, no returns were delivered by the receiving team.The retention samples were satisfactory.Evaluations results: based on the investigation, no defect was observed.Investigation conclusion: based on the evaluation of the investigation, the complaint could not be confirmed.No further action will be taken as no defect was observed and no complaint trend is present on this issue.Bd will continue to monitor for trending.
Event or Problem 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)
• Common Device Name: 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
• Report Number: 1119779-2024-00169
• Device Sequence Number: 19575914
• Product Code: LXG
• UDI-Device Identifier: 00382902202172
• UDI-Public: (01)00382902202172
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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