MAUDE Adverse Event Report: NULL CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Packaging Problem (3007)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that the customer received a concern from one of their in-patient units explaining that in their clean supply rooms, like items are kept together, so all of their administration tubing sets are grouped together on a shelf.The packaging of epidural sets and standard sets are in almost identical packaging, with very similar numbers, however there is a small yellow line running up the epidural package.It was reported that an error occurred where a patient had a pca infusing with an epidural set.The nurse reporting the incident did express her concern, if the situation had been reversed and standard tubing was used with an epidural and didn't have a filter, patient harm is a likely outcome.No patient injury reported.

Manufacturer Narrative

Operator of device: no information has been provided to date.Report source: manufacturing site address is unknown.Catalog number is unknown.Udi information is unknown.Premarket (510k) number is unknown.Device evaluation.The device was not returned for analysis.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: b5: additional information received on 12-sep-2022 via email and attached to complaint object: if this is regarding the amount infused while incorrectly attached, it is unknown but was reported as a full weekend.Date of the event updated: monday july 11, 2022.The reported event occur during patient use; the event did not result in patient harm; medical intervention required: changing over tubing to correct; the outcome of the event was resolved.H6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 15104661
• MDR Text Key: 304103657
• Report Number: 3012307300-2022-14207
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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?: Yes
• 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