MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Partial Blockage (1065); Complete Blockage (1094); Product Quality Problem (1506); Obstruction of Flow (2423); Blocked Connection (2888)

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

Event Type  malfunction  

Manufacturer Narrative

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 the disposable shows crystallization of morphine.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: four photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation is being documented has not been received.Photo one shows a luer connector that is visible occluded with a white substance.Photo two shows a front view of a distal end luer connector from a cassette which is observed to be occluded with a white substance.Photo three shows a label for a extension set, no device is observed in this photo.Photo four shows a cassette; no damage or dysfunctional conditions are observed.The reported failure mode, occluded, is confirmed.After reviewing the mitigations that are performed during the manufacturing process to detect occlusion, and analyzing the photos provided, the root cause cannot be determined.No product has been received to conduct a functional test.If the device arrives, icu will reopen this complaint to include in the investigation the physical sample returned.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16902507
• MDR Text Key: 314908493
• Report Number: 3012307300-2023-05463
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/22/2023
• 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