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

Model Number	SBT-114-100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was about to be used on a procedure, on an unknown date.According to the complainant, during unpacking, it was noted that the bite blox was dirty.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was about to be used on a procedure, on an unknown date.According to the complainant, during unpacking, it was noted that the bite blox was dirty.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block h6: device code 1120 captures the reportable event of contamination during use.Block h10: one bite blox received for analysis in its packaging.Visual analysis of the returned device found that strap of the device has dirt or residue on multiple location.Additionally, the device did not apear used.No other issues noted.The product analysis was not able to confirm if the dirt observed on the strap of the device occurred while the device was in its packaging.Therefore, the most probable cause for this event is cause not established.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the 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 MA 21325 1; CH 213251
• MDR Report Key: 10032521
• Report Number: 3005099803-2020-01836
• Device Sequence Number: 2554012
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 60264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1