MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7324-24
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Event or Problem Description
It was reported that since the switch from epidural cadd cassettes to cadd adaptor tubing with bags about a month ago, there have been several instances where nursing staff were unable to disconnect the luer lock end of the epidural tubing from the epidural filter.A photo from the education epidural line was included for reference.The connection has been described as overly tightened, with some attributing the issue to pressure or fluid buildup at the connection point.There was no reported patient involvement or patient harm.
Additional Manufacturer Narrative
H3: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review could not be performed as the lot number was unknown.
Additional Manufacturer Narrative
D9 - date returned to mfg: 11/6/2025.H3 and h6 codes - updated.Six used partial devices were returned for investigation.The devices were visually inspected.Six asv valves were observed to be connected to an epidural filter with the tubing cut off at the proximal end.One of the asv valves was observed to have tool marring marks on the outer thread surface.No other damages or anomalies were observed.During testing, each asv valve was manually attempted to be removed.Only one out of six were successfully disconnected.The complaint of difficult to disconnect can be confirmed.The probable cause is due to an environmental stress condition where insufficient drying of the disinfectant on the luer connector can cause plastic deformation when connected.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22927131
• Report Number: 3012307300-2025-10157
• Device Sequence Number: 18431001
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: (01)10610586029653(17)241206(10)6071195
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 Expiration Date: 12/06/2024
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 6071195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown