MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. SINGLE LINE LOGICAL PRESSURE MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number MX1452

Device Problems Unable to Obtain Readings (1516); Failure to Zero (1683); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d4: udi section, lot number, expiration date, and h4: manufacture dare are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that no pressure traces were visible, and equipment would not zero.They have tried single and double transducers as well as different batches.Adverse effects are unknown.Event was reported as "ongoing".

Manufacturer Narrative

Other, other text: b5; updated.D3, g1,2 email is: (b)(6).

Event Description

Additional information received via email."there were multiple lots impacted and also a query around the hardware as well as the disposables.As for the dates this has not been an isolated incident at the trust; it happened on a number of occasions in the last 3-4 months.Therefore unable to provide accurate information on this".

Manufacturer Narrative

Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: SINGLE LINE LOGICAL PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18006950
• MDR Text Key: 326532414
• Report Number: 3012307300-2023-09892
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX1452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1