MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7046-24

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 other information provided.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: device evaluation, pictures received: four (4) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time of this investigation is being documented, had not been received.Results: photo ones 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 cadd 250 ml cassette which is observed to be occluded with a white substance.Photo three shows a label for a cadd extension set of part number 21-7046-24 and lot number 4298348; no device is observed in this photo.Photo four shows a cadd 250 ml cassette; no damage or dysfunctional conditions are observed.The reported failure mode, occluded, is confirmed.Functional testing: no product has been received to conduct a functional test.Results: if the device arrives, icu will reopen this complaint to include in the investigation the physical sample returned.Root cause: the customer reported: per email notification.Crystallization of morphine on a cadd extension set.Photos attached in complaint and investigation.No other information provided.Unknown if the device is returning for investigation.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.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16902471
• MDR Text Key: 314907916
• Report Number: 3012307300-2023-05462
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020308
• UDI-Public: 10610586020308
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K942046
• 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

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7046-24
• Device Catalogue Number: 21-7046-24
• Device Lot Number: 4298348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1