MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET?; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7115-24
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Catalog number is unknown.Premarket (510k) number is unknown.Operator of device and initial reporter also sent report to fda are unknown.No information has been provided to date.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 reportable information becomes available.
Event or Problem Description
It was reported on (b)(6) 2022, that there was an incident where the pca tubing and iv tubing had a downstream occlusion on the iv pump that lead to issues with the pca and iv fluids being infused properly.A backflow of blood began to build and was visible in the tubing, and it began to leak at the y site on the pca tubing.The rn who encountered the issue completed an onpoint event report.The tubing was saved and is currently stored in case its needed to be sent back to the vendor.Cadd extension tubing (without the blue line); lot number not available.No patient injury was reported.
Additional Manufacturer Narrative
B5: additional information received on 25-jul-2022 via email and attached to complaint object: patient information updated.No injury noted, however, the patient might have not received full dose of pca (patient-controlled analgesia) medication since there was a leak at the y-site on pca tubing.Issue was resolved: patient was disconnected from malfunctioning tubing at time of event and new pca tubing and iv tubing was used to reconnect patient appropriately.H6: event problem and evaluation codes: updates not required., corrected data: d4: correction: catalog number: 21-7115-24.G5: correction: premarket (510k) number: k000942.
Additional Manufacturer Narrative
H10: device evaluation was completed.No product was returned for investigation.One (1) picture was attached and reviewed.The picture attached show the clear side of a pouch, part of an extension line is visible inside the pouch.Per the picture attached the reported failure mode is not visible.The complaint is not confirmed.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.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).

• Brand Name: CADD EXTENSION SET?
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15066186
• Report Number: 3012307300-2022-13752
• Device Sequence Number: 5722840
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21-7115-24
• Device Catalogue Number: 21-7115-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 04/05/2023
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/25/2022; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 68 KG