MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-546-100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a biteblox device was being prepared for use in a procedure on (b)(6) 2023 upon opening the device package during preparation, a hair was noted inside the package.There were no patient complications reported as a result of this event.Note: a photo of the device was provided by the customer.The photo shows a hair was inside the package.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.
Event or Problem Description
It was reported to boston scientific corporation that a biteblox device was being prepared for use in a procedure on (b)(6), 2023 upon opening the device package during preparation, a hair was noted inside the package.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.Block h10: investigation results one blox bite block was received for analysis.Media analysis of the returned device found a hair inside the sealed bite blox pouch.The reported event of device foreign material present in device is confirmed.The hair is likely a result of the supplier's quality control process, specifically, the manufacturer's ability to control and verify foreign material specifications, as the pouch had not been opened for use, and no damage was observed to the pouch.Therefore, based on all gathered information, the complaint investigation conclusion code selected is quality control deficiency.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LT; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17070645
• Report Number: 3005099803-2023-03025
• Device Sequence Number: 6738735
• Product Code: MNK
• UDI-Device Identifier: 00840253104809
• UDI-Public: 00840253104809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: Health Professional
• Device Model Number: SBT-546-100
• Device Catalogue Number: SBT-546-100
• Device Lot Number: 0000220306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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