MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	MX90128
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three devices were returned for investigation.The returned samples were visually inspected, and the customer's complaint was confirmed.Samples from code mx20119 were visually inspected finding two samples with disconnection defects, one sample with disconnection between the trifurcated adaptor and tube.The cause of the problems were related to the bonding method.A retraining on the proper bonding method was completed and documented.The customer did not provide a valid lot number so dhr could not be completed.
Event or Problem Description
It was reported that during use of the device leaking or breaking occurred.No patient injury was reported.
Additional Manufacturer Narrative
Three devices were returned for investigation.The returned samples were visually inspected, and the customer's complaint was confirmed.Samples from code mx20119 were visually inspected finding two samples with disconnection defects, one sample with disconnection between the trifurcated adaptor and tube.The cause of the problems were related to the bonding method.A retraining on the proper bonding method was completed and documented.The customer did not provide a valid lot number so dhr could not be completed.
Event or Problem Description
It was reported that during use of the device leaking or breaking occurred.No patient injury was reported.

• Brand Name: MEDEX
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 13457690
• Report Number: 3012307300-2022-02604
• Device Sequence Number: 4867093
• Product Code: DRS
• UDI-Device Identifier: 50351688509749
• UDI-Public: 50351688509749
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K951129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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 Catalogue Number: MX90128
• Device Lot Number: 4062905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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