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

Catalog Number 21-7106-24

Patient Problem Chemical Exposure (2570)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Patient was receiving ambulatory infusion of 5-fu over 46 hours.On (b)(6) 2024 at approximately 0630 (~18 hours into the 46 hour infusion), the patient noticed that her shirt had a few wet, circular spots (same size as the disc filter on the extension set) that appeared to be coming from the infusion pump or tubing.Upon further inspection, she noticed the medication was leaking from the little hole of the disc filter.She immediately covered it with tape and it stopped and she proceeded to call the clinic as soon as we opened.The rn instructed her to stop the pump and to come to clinic immediately.Upon arrival, the rn removed the tape and also noted the medication was leaking from the filter hole, recovered it with tape and notified the doctor and pharmacist.The decision was made to prepare a new cassette with the remaining drug to infuse and attach a new extension set.The pump was restarted, the tubing was inspected and no leaks were observed, and the patient was sent home with instructions to return the next day upon completion of the infusion or to call immediately if it happens again.The pharmacist was able to reproduce the leak by reattaching the cassette to the pump and took a picture before disposing of the contents as they were contaminated with 5-fu (hazardous chemotherapy).Note that this is not the first time we have had issues with the cadd supplies.I submitted an fda medwatch on 1/27/2022 with a similar incident where the disc filter was leaking, but at that time it was leaking out the sides of the filter where the 2 discs are fused together during manufacturing.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18873935
• MDR Text Key: 337438457
• Report Number: MW5152519
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 4163597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White