MAUDE Adverse Event Report: ST PAUL CADD-ADMIN SETS, FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Pain (1994)

Event Date 05/25/2022

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.(udi and catalog) is unknown.No product information has been provided to date.

Event Description

It was reported that after receiving a request to evaluate a labor epidural that was not providing the patient adequate pain control, we found that the epidural medication had not been infusing.No patient injury was reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updates not required.H10: no product was returned for visual or functional evaluation.Results: we are unable to confirm the reported complaint as no sample was received for investigation.Root cause of the reported event cannot be determined as no sample was received for investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No lot number was provided therefore, a manufacturing device history record dhr review could not be performed.

• Brand Name: CADD-ADMIN SETS, FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15262287
• MDR Text Key: 305059044
• Report Number: 3012307300-2022-11896
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• 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