MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	74921-02
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A contaminated sample was returned and after decontamination the issue was confirmed.It was noted there was a clean break in the area where the tip is bonded to the wand of the suction wand.The device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed for this component the supplier had performed 100% sucker/tip bend strength testing for the raw material lot.The sample was forwarded to the supplier for further evaluation.The supplier noted the break occurred outside the bonded area.The bonding areas showed to have held the bonded seal and the break was above the actual bonded area between the handle and tip.The supplier stated the break as a pressure break, highly likely due to misuse of the product.The supplier also reviewed their dhr records for the raw material lot going back 5 years and verified no complaints on the product were recorded.According to the instructions for use for the component "caution: care should be exercised when applying force to any sucker or sump set since excessive bending of the tube or tip could cause breakage." all available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.The case label gtin: (b)(4).The production identifier: (b)(4).
Event or Problem Description
The customer reported that during cardiopulmonary bypass (cpb) procedure, the sucker in the pack came apart and the piece had to be removed from the chest.They stopped using this suction wand and completed the surgery without incident.The product was not changed out and surgery was completed successfully.There was no delay reported, no blood loss and no adverse event reported.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 12486915
• Report Number: 1212122-2021-00006
• Device Sequence Number: 3392347
• Product Code: OEZ
• UDI-Device Identifier: 00699753499188
• UDI-Public: (01)00699753499188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 74921-02
• Device Lot Number: Z23959047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR