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

Catalog Number	MX9604A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: no device was returned for investigation.In lieu of that, a photo was returned.Review of the photo confirms the customer complaint.In order to see if the issue could be replicated, investigators used devices of the same lot number and applied various methods to replicate the error in the photo.The investigator was able to replicate the break when extra force was applied to the device.Most probable but undetermined root cause was found to be excessive force used while handling the device.Review of the device history record shows no non-conformities during the manufacturing procedure of the reported lot number.
Event or Problem Description
It was reported that the material tip showed breakage when connecting to the vial.The event occurred in the intensive care unit.The customer reported that no harm came to the patient due to this issue.The patient had flu sydrome, acute cri and hyperkalemia.The patient was treated with medication and the issue was resolved.Due to the reported issue, the patient was exposed to repeated procedure and a therapeutic delay.The sample is not available for investigation, however a picture was provided.

• Brand Name: MEDEX SINGLE LINE PRESSURE MONITORING KIT
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17669542
• Report Number: 3012307300-2023-08620
• Device Sequence Number: 15225775
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: 10351688502933
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K172485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: MX9604A
• Device Lot Number: 4199957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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 Age: 81 YR
• Patient Sex: Male