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

Model Number	SBT-114-100
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: (b)(6).Block h6: device code a1802 captures the reportable event of foreign material present in the packaging.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used on unknown date.It was reported that there was a hair found in the packaging.The procedure was completed with another bite blox.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by the sales representative.The healthcare facility (b)(6).Block h6: device code a1802 captures the reportable event of foreign material present in the packaging.Block h11: the returned bite blox was analyzed.The pouch itself was unopened, and no visual defects/damage was noted with the pouch.No evidence of damage was observed to the bite blox inside the pouch.Visual inspection of the pouch interior noted presence of a single hair.Product analysis confirmed the reported event of foreign material present in the packaging.Upon visual inspection of the returned unopened pouch confirmed that a single hair was present.Therefore, a review and analysis of all available information indicated the most probable cause is quality control deficiency, which indicates that the problems can be traced to the failure to maintain or establish techniques for controlling and verifying the product specifications including implied but undocumented specifications.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used on unknown date.It was reported that there was a hair found in the packaging.The procedure was completed with another bite blox.There were no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22543420
• Report Number: 3005099803-2025-03338
• Device Sequence Number: 17896024
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: (01)00816849010168(11)240914(10)240914
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: Health Professional
• Device Model Number: SBT-114-100
• Device Catalogue Number: SBT-114-100
• Device Lot Number: 0000240914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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