MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LOGICAL KIT; PRESSURE MONITORING

Catalog Number DPS564928

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that the connecting screw between the red 3-way stopcock and the blue 3-way stopcock loosens again by itself during operation.This is first noticeable by falling blood pressure values, only late then the measurement stops completely.Then, of course, the puddle formation on the floor is noticeable.Additionally it was reported that disconnection was at a connection point without external influence.

Manufacturer Narrative

Other, other text: a review of the device history records revealed no observations recorded during manufacture to suggest an issue of this nature would occur.

Manufacturer Narrative

H10: no product or photographic evidence was provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use ifu or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, the complaint will be reopened for further investigation.No lot or serial number was provided therefore, a device history record dhr review could not be performed.

• Brand Name: MEDEX LOGICAL KIT
• Type of Device: PRESSURE MONITORING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15164433
• MDR Text Key: 297240269
• Report Number: 3012307300-2022-14673
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DPS564928
• Device Lot Number: 4245650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other