MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE; PUMP, INFUSION

Model Number	7001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were 17 packs and 4 cassettes in each package where there was a packaging error.The site discovered that a number of cassettes had a packaging fault, where a different instruction for use (ifu) document was inserted within the sealed packaging for a different item number of a different cassette product.The issue was discovered after some of the samples were potentially sent out to patients.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
H3, h6: 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 information becomes available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
H6: evaluation codes updated device evaluation: two samples were received.The samples were received in non-used condition, decontaminated and with its original packaging inside a plastic bag.During the visual inspection, a discrepancy on the ifu was observed.The ifu included on the pouch the part number 21-7301-24 but the device part number is 21-7001-24.The failure mode was confirmed.Service history identified that no previous repair has been noted for this lot in the last 12 months.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
Update: gcm received an email on 20-aug-2024 from (b)(6), from facility (b)(6), stating that they discovered that a number of cadd medication cassettes had a packaging fault, item 21-7002-24 had a different ifu inserted within the sealed packaging for item 21-7301-24 cadd cassette 50ml flow stop.The actual product inside was item 21-7002-24.The device is available for investigation.The issue was discovered after some of the samples were potentially sent out to patients.All stock was checked and affected stock was quarantined.No medical intervention was required.There was no patient harm.Pmitrofan (b)(6) 2024.Update: in clarification to the above documentation, the packaging fault for the product with item number 21-7001-24 and lot number 4349110 was not specified by the customer using different item numbers.The error described about the product with a different item number applies to the referenced associated complaint.Pmitrofan (b)(6)2024.Update: in clarification to the above documentation, gcm received an email on 20-aug-2024 from (b)(6), from facility (b)(6), stating that they discovered that a number of cadd medication cassettes had a packaging fault.Pmitrofan (b)(6) 2024.

• Brand Name: CADD MEDICATION CASSETTE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20208502
• Report Number: 3012307300-2024-09054
• Device Sequence Number: 12713130
• Product Code: FRN
• UDI-Device Identifier: 10610586022111
• UDI-Public: (01)10610586022111(17)271204(10)4349110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843772
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

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 Model Number: 7001
• Device Catalogue Number: 21-7001-24
• Device Lot Number: 4349110
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 01/08/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/18/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2022
• 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