MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTERVENTIONAL IMAGING

Model Number	MX693R
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a interventional imaging|medex high pressure tubing malfunctioned.The report indicated that on two different occasions the tubing ruptured when doing pump pressure injection during a procedure.Rated for 900psi, were using 700-800 psi.No patient injury during procedure was reported.
Additional Manufacturer Narrative
Other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Conclusion: the defect reported could not be attributable to the manufacturing process, since the 46 samples passed the high pressure test and the reported lot was found within specifications during high pressure test during its manufacture.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: MEDEX
• Common Device Name: INTERVENTIONAL IMAGING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11685527
• Report Number: 3012307300-2021-03262
• Device Sequence Number: 14206991
• Product Code: FPA
• UDI-Device Identifier: 10351688505811
• UDI-Public: 10351688505811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: MX693R
• Device Catalogue Number: MX693R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1