MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX FDA CLEARED CLEAR-CUFF PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	MX4710
Medical Device Problem Codes	Leak/Splash (1354); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product leaked and the required pressure for use was not reached.No patient injury was reported.
Additional Manufacturer Narrative
Premarket (510k) number is unknown.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.Four (4) units were returned for evaluation.Unit 1 and unit 2.Visually inspected on receipt and appears to be assembled correctly.Bags had uci written on bag in black marker and no other markings.Unable to duplicate any failure on this unit as noted in description on complaint.Unit 3 visually inspected on receipt and appears to be assembled correctly.Unable to duplicate any failure on this unit as noted in description on complaint.Unit 4 : visually inspected on receipt and appears to be assembled correctly.Unit was received with uci written on bag, additionally during visual inspection it was noticed the tip of the gauge indicator rod was bent.The root cause unable to be determined for the leak although with the rod tip bent it appears the unit may have had a force applied to the unit after release from production.Unit #4, the reported problem of leaking was duplicated.Unit was leak tested under water and found to leak around the top cap of the gauge assembly.The indicator rod tip was bent and it appeared that the unit may have had a force applied to it after release from production.Root cause unable to be determined.No causes or potential causes to the customer's reported problem were found during the device history record (dhr) review.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: MEDEX FDA CLEARED CLEAR-CUFF PRESSURE INFUSOR
• 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; edificio medical depot; minneapolis, MN 55442
• MDR Report Key: 15401709
• Report Number: 3012307300-2022-18646
• Device Sequence Number: 20378194
• Product Code: KZD
• UDI-Device Identifier: 10351688507020
• UDI-Public: 10351688507020
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: MX4710
• Device Catalogue Number: MX4710
• Device Lot Number: 3929765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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
• Patient Ethnicity: Hispanic