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

Lot Number 3912351

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Picture was provided for the analysis of this complaint, it was observed a hole near the border of the tab area.It was not possible to confirmed with the picture provided if the white protector was included on the reported non-conforming piece.Also, no air leak test could be performed as the part was not provided.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Model#, operator of device, initial reporter also sent reports to fda, and pma/510k are unknown.No information has been provided to date 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 device has leakage.Failure analysis determined that the membrane caused the leakage failure.No patient injury was 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; minneapolis, MN 55442
• MDR Report Key: 15396828
• MDR Text Key: 305698963
• Report Number: 3012307300-2022-18407
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Lot Number: 3912351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1