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

Model Number 21-7106-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pulmonary Hypertension (4460)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: 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 information becomes available.

Event Description

It was reported that there was an increase in the number of complaints related to leaking of the extension set.Per reporter (b)(4) patients were affected between january to june, 2023.No major patient injury issues were reported but some patients mentioned exhibiting pulmonary arterial hypertension symptoms.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned this complaint will be reopened for further investigation.

• Brand Name: CADD EXTENSION SET
• 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: 17350795
• MDR Text Key: 319320625
• Report Number: 3012307300-2023-07242
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 4309417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1