MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DIV18 CRITICAL CARE - MISCELLANEOUS

Catalog Number DIV18

Device Problem Break (1069)

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

Event Date 01/22/2024

Event Type  Injury  

Event Description

According to the customer, on (b)(6) 2024 the temp probe "detached" from the foley catheter when the patient arrived in the icu after a procedure and the foley was replaced.

Manufacturer Narrative

According to the customer, on (b)(6) 2024 the temp probe "detached" from the foley catheter when the patient arrived in the icu after a procedure and the foley was replaced.The customer did not report any serious injury.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Manufacturer Narrative

Update to h6: investigation conclusions.

• Type of Device: DIV18 CRITICAL CARE - MISCELLANEOUS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18980203
• MDR Text Key: 338620856
• Report Number: 1417592-2024-00443
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DIV18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other