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

Model Number MX4705

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Protocol number: premarket (510k) number is unknown.No product returned.Investigation completed using photos provided.Photo shows the tubing being out of the blue gauge assembly, using photos provided unable to determine if there is solvent attack present at the end of the tubing end pulled from gauge assembly or if the tubing has breakage.Each unit is 100% percent leak tested prior to release, so no indication of leak or tubing issues ( no solvent bond or breakage) was present prior to release.Without benefit of the actual part unable to confirm a root cause.No causes or potential causes to the customer's reported problem were found during the dhr review.No inventory remaining of this lot# for additional review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the cardiology department had a leak when it was ready for use, it was found that the connection was cracked and could not be used under pressure.No patient injury reported.

• Brand Name: MEDEX CLEAR-CUFF PRESSURE INFUSOR
• Type of Device: 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; linqing city; minneapolis, MN 55442
• MDR Report Key: 15397690
• MDR Text Key: 305631942
• Report Number: 3012307300-2022-18511
• Device Sequence Number: 1
• Product Code: KZD
• UDI-Device Identifier: 10351688507037
• UDI-Public: 10351688507037
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MX4705
• Device Catalogue Number: MX4705
• Device Lot Number: 4076834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1