MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUCTION TUBING

Model Number	SVT-089
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 suction tubing was to be used on a colonoscopy procedure, performed on (b)(6) 2020.According to the complainant, during set up, a hard, dark solid material was found stuck in the tubing.Another compliance kit was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block f10 and h6 are updated.Block d4: this is a non-sterile device with no expiration date.Block h6: device code 2944 captures the reportable event of foreign matter within package.Block h10: one compliance kit was returned for analysis.Visual inspection of the returned suction tubing found that there was a large, dark mass of foreign material stuck inside the tubing.The tubing was returned coiled, with the label still attached and the device showed no signs of use.The remaining components were all in their individual packaging.No other issue noted.Based on communications from the supplier, the root cause is that some of their employees in the extrusion workshop did not carry out the equipment maintenance and cleaning in the workplace, and the assembly workers did not conduct enough self inspection of the products.Through investigation, the foreign matter is a burnt resin produced at the end of extruder screw.Due to the previous production workload was too saturated, the equipment in the extrusion workshop could not be cleaned regularly in time according to the requirements outlined in the company's cleaning procedure, resulting in the burnt particles stuck inside the tubing during the extrusion process, and the workers failed to find notice the issue during assembling.Therefore, the most probable cause for this event is manufacturing deficiency.An investigation is in place to address this problem.
Event or Problem Description
It was reported to boston scientific corporation that suction tubing was to be used on a colonoscopy procedure, performed on (b)(6) 2020.According to the complainant, during set up, a hard, dark solid material was found stuck in the tubing.Another compliance kit was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: SUCTION TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10697807
• Report Number: 3005099803-2020-04660
• Device Sequence Number: 3259407
• Product Code: GAZ
• UDI-Device Identifier: 00840253111999
• UDI-Public: 00840253111999
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: SVT-089
• Device Catalogue Number: 2106-01
• Device Lot Number: 0000191015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1