MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX PRESSURE INFUSION C-FUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	MX4810
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Unit(1 and 2) returned without bulb assembly.Unit has yellow tinge on the bag material with scratches along with writing on black marker at the top of the bag.The reported complaint can not be confirmed due to unit had a bulb assembly attached and appears to function as required with the gauge indicator needle moving up when pressure applied and returning to zero with zero pressure applied.The root cause of the reported issue was unable to be confirm.The bulb assembly came apart as noted in complaint without bulb assembly being returned and age of supplied unit as lot appears top be made in 1998.The root cause for the tubing bond pulling out is undetermined as only one units returned had the entire components for review.The tubing and luer are solvent bonded together and will break loose with enough supplied force.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that the inflating bulb was breaking off the stop and cannot put it back on which caused the bag to leak.No patient injury was reported.

• Brand Name: MEDEX PRESSURE INFUSION C-FUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• 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: 15396917
• Report Number: 3012307300-2022-18423
• Device Sequence Number: 5183628
• Product Code: KZD
• UDI-Device Identifier: 50351688507004
• UDI-Public: 50351688507004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: Other
• Device Model Number: MX4810
• Device Catalogue Number: MX4810
• Device Lot Number: 3901714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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