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

Model Number 21-7092-24

Device Problem Crack (1135)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

Event Description

It was reported that the cadd tubing broke off where the saline and narcotic lines meet, while untangling the lines.No injury was reported.The lot number is unknown.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One decontaminated sample was returned for evaluation and the sample was analyzed.The sample was observed broken and the complaint was confirmed.Based on the sample returned by the customer it was not possible to replicate the issue and confirm that it was a manufacturing process issue.The most probable root cause was incorrect method in the use of the product by the customer or incorrect handling.

• Brand Name: CADD EXTENSION SETS
• 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: 14366444
• MDR Text Key: 291497493
• Report Number: 3012307300-2022-08610
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: 10610586024177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000942
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7092-24
• Device Catalogue Number: 21-7092-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• 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
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American