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

Model Number	SBT-114-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Airway Obstruction (1699); Cardiac Arrest (1762); Respiratory Insufficiency (4462)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure.During the procedure, a loud snap was heard when the patient bit down on the bite blox.The device was checked and appeared to be intact, so the case was continued.The physician reported that the patient was not breathing, and heart rate was dropping; a code was called.The physician attempted to administer the anesthesia to intubate the patient; a piece of green plastic was noted in the patient's airway.The broken piece was removed using forceps.The procedure was completed with another of the same device.In the physician's assessment, the device contributed to the patient complications and it is unknown if the patient has any co-morbidities that could have contributed to the event.Reportedly, the patient was not admitted to hospital beyond the standard of care and got fully recovered.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 01/01/2025 as no event date was reported.Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Imdrf patient code e0702 captures the reportable event of airway obstruction.Imdrf patient code e0602 captures the reportable event of cardiac arrest.Imdrf impact code f1203 captures the reportable event of life-threatening illness or injury.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.H11: the complainant was unable to confirm the correct batch/lot number of the complaint device (b)(4).Additional information will be provided upon return of the device.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 01/01/2025 as no event date was reported.Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Imdrf patient code e0702 captures the reportable event of airway obstruction.Imdrf impact code f1203 captures the reportable event of life-threatening illness or injury.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.H11: the complainant was unable to confirm the correct batch/lot number of the complaint device (240604 or 240712).Additional information will be provided upon return of the device.Correction to block h6 (imdrf patient code).
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure.During the procedure, a loud snap was heard when the patient bit down on the bite blox.The device was checked and appeared to be intact, so the case was continued.The physician reported that the patient was not breathing, and heart rate was dropping; a code was called.The physician attempted to administer the anesthesia to intubate the patient; a piece of green plastic was noted in the patient's airway.The broken piece was removed using forceps.The procedure was completed with another of the same device.In the physician's assessment, the device contributed to the patient complications and it is unknown if the patient has any co-morbidities that could have contributed to the event.Reportedly, the patient was not admitted to hospital beyond the standard of care and got fully recovered.No further information has been obtained despite good faith efforts.

• 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 WI 21324 1; CH 213241
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21355885
• Report Number: 3005099803-2025-00429
• Device Sequence Number: 12999538
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SBT-114-100
• Device Catalogue Number: SBT-114-100
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/10/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown