MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS); EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDI

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	07/31/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while using bd calibrated disposable inoculating loops, blue 10¿l (20x50 loops), the coc shows incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer reports that the coc shows the product as 1 ul as opposed to 10 ul.".
Event or Problem Description
It was reported that while using bd calibrated disposable inoculating loops, blue 10l (20x50 loops), the coc shows incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer reports that the coc shows the product as 1 ul as opposed to 10 ul.".
Additional Manufacturer Narrative
H.6.Investigation summary: this memo serves to summarize findings on your recent complaint 8559068 on product 220217 (loops inoculating 50/tube 10 microliter), lot number 2301037, where it was observed that the material description on the certificate didn¿t match the product labeling.Event description: " customer reports that the coc shows the product as 1 ul as opposed to 10 ul." 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 device history record did indicate that the product description on the certificate was incorrect.Sample analysis: no photos or returns were available.An inspection of the retention samples did not show the noted defect.Evaluations results: based on the investigation, the noted defect was observed in the device history record.An error in the creation of the certificate was the cause of the discrepancy.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.A review of complaints does not indicate that a trend is present.No further action will be taken as this is considered to be an isolated incident.

• Brand Name: BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS)
• Common Device Name: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDI
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17495625
• Report Number: 1119779-2023-00869
• Device Sequence Number: 20646117
• Product Code: LXG
• UDI-Device Identifier: 00382902202172
• UDI-Public: 00382902202172
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 2301037
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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