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

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problem Pain (1994)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Other, udi number and catalogue number is unknown.Device manufacturing date and d4: device expiration date are unknown.Device serial number/lot number is unknown.Health effect and evaluation codes: updated.No lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received from the decontamination site to the investigation site; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is received, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# (b)(6).

Event Description

It was reported of a device presenting bubbles in the tubing and under-delivering infusion.New epidural and pump were set up and extra bolus of pain medication was administered.No patient injury was reported.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.No damage or other defects were detected on the sample during visual inspection.Functional testing could not duplicate or confirm the failure mode reported.Test passed successfully.No lot number was provided, therefore no device history report (dhr) review could be completed.Root cause cannot be determined since complaint was not confirmed.No action taken is required since complaint was not confirmed.

• Brand Name: CADD ADMINISTRATION 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: 17221718
• MDR Text Key: 318069764
• Report Number: 3012307300-2023-06832
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1