MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SIT-576-15
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	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydra irrigation tubing was being prepared for use in a procedure on (b)(6) 2024.Upon opening the device package during preparation, a hair was found inside the sealed device package.The procedure was completed using another of the same device.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a hydra irrigation tubing was being prepared for use in a procedure on (b)(6) 2024.Upon opening the device package during preparation, a hair was found inside the sealed device package.There was no patient involvement with this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Block h10: investigation results the returned hydra irrigation tubing was analyzed.Visual evaluation found that the presence of a foreign material (hair/strand) inside the unopened device pouch.No other problems were noted.The reported event was confirmed.According to the manufacturer pfmea, current process controls include inspection and check during the seal pouch process for 5 pieces every 2 hours.Therefore, it is likely that this device was not one of the 5 pieces inspected and the presence of a foreign material was missed for this device.Based on all available information and analysis of the returned device, the most probable cause 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.

• Brand Name: HYDRA
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• 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: 18835755
• Report Number: 3005099803-2024-00827
• Device Sequence Number: 15336625
• Product Code: FEQ
• UDI-Device Identifier: 00840253108401
• UDI-Public: 00840253108401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: TC
• PMA/510(K) Number: K161482
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Model Number: SIT-576-15
• Device Catalogue Number: SIT-576-15
• Device Lot Number: 0000230923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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