MAUDE Adverse Event Report: OBP MEDICAL CORPORATION ONETRAC LXS YANKAUER; YANKAUER SUCTION CANNULA

Catalog Number	C110220
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report was made directly to fda with anonymity - customer communication is not possible.Lot number was not provided so detailed device history record review cannot be conducted.The product was not returned for investigation, photos were not provided, and user was not available to provided additional details / respond to questions, and the reported failure mode was therefore not confirmed.A sample of finished devices received in every delivery is subjected to a destructive incoming inspection, which includes visual particulate / contamination inspection (which is also implemented in production).A review of non-conforming material reports confirmed no ncmr have been logged for contamination.A review of complaint records confirmed no similar complaints have been received or otherwise identified.A root cause cannot be concluded - not enough information was provided to confirm implemented risk control measures and/or production processes are ineffective, no action plan is deemed required.
Event or Problem Description
Company received a copy of medwatch fda cars generated 3500-series form - problem report from medical device reporting team, cdrh.Problem described on form as follows, "the product from obp surgical, "onetrac lxs yankauer" should be sterile and inside of a sterile package.However, on numerous occasions sterility has been compromised.It has been noted that there has been human hair, and other debris inside of the sterile packaging which could risk infections and other complications for the patient.".

• Brand Name: ONETRAC LXS YANKAUER
• Common Device Name: YANKAUER SUCTION CANNULA
• Manufacturer (Section D): OBP MEDICAL CORPORATION; 360 merrimack st.; building 9; lawrence MA 01803
• Manufacturer (Section G): HANGZHOU FUSHAN MEDICAL APPLIANCE CO., LTD.,; no. 1288 south jinxi road; linglong industry park; lin'an, zhenjiang 31130 1; CH 311301
• Manufacturer Contact: kate leslie ; 360 merrimack st.; building 9; lawrence, MA 01843 ; 9782916853
• MDR Report Key: 20294718
• Report Number: 3007789561-2024-00001
• Device Sequence Number: 7208776
• Product Code: JOL
• UDI-Device Identifier: M648C1102200
• UDI-Public: M648C1102200
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: Health Professional
• Device Catalogue Number: C110220
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown