MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) SEE H.11

Catalog Number	220215
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd calibrated disposable inoculating loops, green 1l (20x50 loops), there was mold contamination which led to false results.There was no report of patient impact.
Additional Manufacturer Narrative
D1: medical device brand name: bd calibrated disposable inoculating loops, green 1l (20x50 loops).D2a: common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.Investigation summary: 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: a review of the photos did show black matter on the plastic loop shafts.No returns were available.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the complaint was confirmed on photos.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.There is no complaint trend on this issue.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.No further actions will be taken as no confirmed trend has been identified.This is an isolated incident.Bd will continue to monitor for trending.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: SEE H.11
• Common Device Name: SEE H.11
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22932896
• Report Number: 1119779-2025-04687
• Device Sequence Number: 21421047
• Product Code: LXG
• UDI-Device Identifier: 00382902202158
• UDI-Public: (01)00382902202158(11)220713(17)270531(10)2209244
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 220215
• Device Lot Number: 2209244
• 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: 06/21/2023
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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