MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7391-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that it was reported that the acute pain service had been notified of two incidences in the last two weeks when a patient controlled analgesia had not delivered the dose it was programmed to do.The patient controlled analgesia pump had alarmed saying the opioid bag was almost empty and when the registered nurse had gone to change the bag, they had noticed that the opioid bag was full and there was a disparity between what the pump says it had delivered and what was remaining in the opioid bag.The last incident occurred on saturday morning.They can confirm that the bag was changed at 0140 by ward staff as the patient had used the amount in the bag, so the pump and line was working then.Then checked the amount discarded from the bag at that time.The new bag commenced was 'spiked' properly but there was air in the line to the cassette.The pump had not alarmed.The patient was sore, and the patient controlled analgesia said the patient had used 88mls of the drug but when the registered nurse changed the bag there was 100mls remaining.Event occurred at hospital while in use with patient.Operator of device was a health professional.There was no patient harm/adverse event reported.Other affected product with same issue was documented under complaint file: (b)(4).There was patient involvement.
Additional Manufacturer Narrative
Received one device.Visual inspection found no damages or anomalies.Device passed all testing.The pump and admin set system are within the accuracy specifications of ±6%.The complaint of delivery accuracy cannot be confirmed nor replicated.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): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21961828
• Report Number: 9617604-2025-00212
• Device Sequence Number: 7151682
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: (01)10610586027512(17)290923(10)6037663
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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 Catalogue Number: 21-7391-24
• Device Lot Number: 6037663
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown