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

Model Number	MX4805
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit received for investigation and was clean in appearance with no markings.Unit received with cracking evident in the stopcock ports along with cracking in the luer lock that attached to the c port of the stopcock.Functional: unit was manually pumped up by using the bulb assembly attached to approximately 400mmhg and allowed to set to observe for leaks, the assembly was observed to have a slow leak and confirmed to be leaking through the cracking on the stopcock ports.Unable to determine root cause for cracking as found although cracking is typical with stress caused by excess tightening or chemical attack.Unable to perform device history record review as no product with this lot number remained in inventory for additional inspection.510(k) exempt this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the bag will inflate, however does not retain pressure, empties gradually.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: 15454982
• Report Number: 3012307300-2022-19739
• Device Sequence Number: 6881378
• Product Code: KZD
• UDI-Device Identifier: 50351688507011
• UDI-Public: 50351688507011
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: MX4805
• Device Catalogue Number: MX4805
• Device Lot Number: 3809193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• 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: 07/25/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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