MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX TRANSTAR PRESSURE MONITORING KIT

Catalog Number MX9505CZ

Device Problem Break (1069)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

No lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Device serial number/lot number is unknown, no product information has been provided to date.

Event Description

It was reported that during transfer to the scanner table while the patient was intubated and ventilated, arterial blood was seen rising in the tubing.The device was found broken near the flush clamp.No clinical consequences observed.

Manufacturer Narrative

H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during the manufacturing process of the device.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: d4: correction: lot number: 4097203.D4: correction: device expiration date: 13-jan-2026.H4: correction: device manufacturing date: 25-jan-2021.

• Brand Name: MEDEX TRANSTAR PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15521654
• MDR Text Key: 306319376
• Report Number: 3012307300-2022-20562
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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 Operator: Health Professional
• Device Catalogue Number: MX9505CZ
• Device Lot Number: 4097203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1