MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ULTRA SMALL BORE EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX613H
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device's iv lipid filter is not allowing lipids to pass through from iv tubing into the filter changing the filter did not fix the issue.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation ((b)(6) 2022): one (1) used decontaminated sample outside its original package was received for investigation at mmon site.Sample which arrive is from code mx448hfb, not the reported code mx613h.A visual inspection and functional test were performed.Visual inspection: returned device was inspected under magnification identifying the occlusion point and the cause of occlusion.Results: it was identified occlusion on union of fll 550-102 and tube 105cd-02.Excess of solvent was identified as the cause of occlusion.Functional test: returned device was tested for water leak according to procedure mty-m-181 rev.102: monterrey assembly functional specifications and water/leak test.Result: one of the 3 fluid lines were occluded.Conclusion: through the analysis of returned device, it was concluded that the occlusion is caused due to solvent excess inside the tube during the bonding process.Defect was not detected during 100% obstruction test executed by production, as a black tape was adhere to the fixture m1120 which could potentially blocked the visibility of the operator to detect an obstruction condition on the product.Black tape was removed from the fixture m1120 to allow the test to be more visible for the operator.Awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held, documented on folio (b)(4) completed (b)(6) 2022.Complaint data was reviewed on 04/feb/2022 and after reviewing the complaints history from february 2019 to date, it was found that this is the 2nd complaint related to occluded/blockage defect on the reported code: mx613h.Previous complaint (b)(4) was confirmed and actions taken.Lot 4206678 from pn: mx613h was manufactured on smiths medical mmon site on (b)(6) 2021 per (b)(4) pieces.No discrepancies were observed during the manufacturing of this lot.The cause of the reported problem was traced to manufacturing process.
Additional Manufacturer Narrative
Device evaluation ((b)(6) 2022): one (1) used decontaminated sample outside its original package was received for investigation at (b)(4) site.Sample which arrive is from code mx448hfb, not the reported code mx613h.A visual inspection and functional test were performed.Visual inspection: returned device was inspected under magnification identifying the occlusion point and the cause of occlusion.Results: it was identified occlusion on union of fll 550-102 and tube 105cd-02.Excess of solvent was identified as the cause of occlusion.Functional test: returned device was tested for water leak according to procedure mty-m-181 rev.102: monterrey assembly functional specifications and water/leak test.Result: one of the 3 fluid lines were occluded.Conclusion: through the analysis of returned device, it was concluded that the occlusion is caused due to solvent excess inside the tube during the bonding process.Defect was not detected during 100% obstruction test executed by production, as a black tape was adhere to the fixture m1120 which could potentially blocked the visibility of the operator to detect an obstruction condition on the product.Black tape was removed from the fixture m1120 to allow the test to be more visible for the operator.Awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held, documented on folio (b)(4) completed (b)(6) 2022.Complaint data was reviewed on 04/feb/2022 and after reviewing the complaints history from february 2019 to date, it was found that this is the 2nd complaint related to occluded/blockage defect on the reported code: mx613h.Previous complaint (b)(4) was confirmed and actions taken.Lot 4206678 from pn: mx613h was manufactured on smiths medical (b)(4) site on (b)(6) 2021 per (b)(4) pieces.No discrepancies were observed during the manufacturing of this lot.The cause of the reported problem was traced to manufacturing process.
Event or Problem Description
It was reported the device's iv lipid filter is not allowing lipids to pass through from iv tubing into the filter changing the filter did not fix the issue.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The leakage is related to a supplier issue.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: MEDEX ULTRA SMALL BORE EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13586691
• Report Number: 3012307300-2022-03987
• Device Sequence Number: 4409966
• Product Code: FPA
• UDI-Device Identifier: 10351688506290
• UDI-Public: 10351688506290
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Expiration Date: 10/04/2024
• Device Model Number: MX613H
• Device Catalogue Number: MX613H
• Device Lot Number: 4206678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown