MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; BAG, RESERVOIR

Model Number	101/870/070CZ
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that twenty-eight (28) days after starting to use the product, the customer noticed the inflation line was detached from the pilot balloon.No patient injury.No additional information is available.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.One used decontaminated sample 10009163-002 7mm deht blu suctionaid sub-assy was returned for investigation without its original packaging.Under visual inspection we noticed that inflation line was detached from pilot balloon.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.The analysis performed in the sample received concluded that the occurrence of this failure condition could be caused by: not enough thf solvent at joint cause by bad condition on the thf feeder system equipment.The cause of the reported problem was traced to the manufacturing process.Any relevant dmrs, ncrs, ets: there no relevant non-conformance (ncr's) or engineering test (et) for this lot.

• Brand Name: PORTEX TUBES BLUSELECT
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13195169
• Report Number: 3012307300-2022-00317
• Device Sequence Number: 11826585
• Product Code: BTC
• UDI-Device Identifier: 15019517076202
• UDI-Public: 15019517076202
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 101/870/070CZ
• Device Catalogue Number: 101/870/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown