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

Device Problem Failure to Infuse (2340)

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

Event Type  malfunction  

Manufacturer Narrative

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.No information has been provided to date.No product information has been provided to date.

Event Description

It was reported that the cassette was faulty.No patient injury was reported.

Manufacturer Narrative

Other, other text: b5: customer response june 24, 2022.Addition information received: patient information (initials, patient sex and dob), and operator of the device (patient).The event was reported during the use with the patient.The outcome was: resolved.Device is not available for investigation.Further information unknown.D5: correction: operator of the device: patient/consumer.

Manufacturer Narrative

H4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.If the product is returned however, the manufacture will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed.

• Brand Name: CADD CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 14876919
• MDR Text Key: 303144028
• Report Number: 3012307300-2022-12760
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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
• Patient Sex: Female