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

Model Number	MX4710
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Four (4) units were returned for evaluation.They were visually inspected and all 4 units appeared to be assembled correctly.Visually inspected on receipt and appears to be assembled correctly.On units 1,2, and 3, bags have uci written on bag in black marker and no other markings.Functionally tested bag assembly by manually pumping the squeeze bulb and unit performed as required.Functional leak test showed that, for 3 of the 4 units, the reported problem was not duplicated.Unit 4 - 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 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.The root cause unable to be determined.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
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.

• Brand Name: MEDEX FDA CLEARED CLEAR-CUFF PRESSURE INFUSO
• 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: 15396848
• Report Number: 3012307300-2022-18400
• Device Sequence Number: 6179409
• 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): 09/09/2022

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: 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: 09/09/2022
• 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