MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTRAVASCULAR ADMINISTRATION SET

Model Number	FS113
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with low cbs had iv fluids noted to be leaking below the filter.The filter set was changed and no more leaking was noted.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.Water leak test: returned sample was tested at 20psi for water leak.The sample exhibited leakage condition at the filter.Visual inspection: the bonding of tube with filter was inspected.The lack of solvent was observed on the bonding of tube with filter.Leakage at filter defect.The complaint issue was confirmed.Actions taken: supplier corrective action report was issued to industrie borla supplier.Additionally, lot 8925/21 available at warehouse of filter pn: p1123-07 was inspected according to inspection procedure for filter, to corroborate if pieces did not exhibit leakage condition as the sample returned from customer.Results: no defects were observed on a sampling of 80 pieces per lot for leakage test.Leakage at bonding of tube with filter was not confirmed.Manufacturing process was reviewed, it was observed fixture m1237 is used to avoid occlusion defect by letting positive air pressure flow inside the tube, while is being dipping into the solvent, to avoid the solvent getting touch with the internal walls of the tube and causing occlusion.According to manufacturing routine, the positive air pressure of the fixture must be set at 0.021 +/- 0.003 mpa, it was observed that the manometer used does not have the correct resolution and therefore the operator could not set it accordingly.Conclusion: it was concluded that the most likely root cause of lack of solvent defect, is related to the air pressure not being set to established pressure range and causing the air to produce a lot of bubbles and making difficult for the operator to observed if the external walls of the tube were totally impregnated of solvent.Action taken: a manometer was changed to a digital type that displays accurate air pressure.Awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held and completed.Conclusion: the root cause of the leakage found in the filter is related to a supplier issue.

• Brand Name: MEDEX
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13122276
• Report Number: 3012307300-2021-13526
• Device Sequence Number: 11925750
• Product Code: FPB
• UDI-Device Identifier: 10351688510983
• UDI-Public: 10351688510983
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: FS113
• Device Lot Number: 4185124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 05/12/2023
• 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