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

Model Number	21-7044-24
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that administration set was discovered broken near the connection point with the broviac line.A small wet patch on the bed suggested that it had been broken and disconnected from the patient for a few minutes.It was impossible to establish exactly how long, but it was somewhere between 23.30 and 00.30.It must have become disconnected when the patient turned in bed.Mum was alerted immediately.She replaced the administration set and reconnected the infusion using aseptic technique.The patient appeared well and stable following this.All vitals remained adequate, no adverse reactions as a result of the incident noticed.
Additional Manufacturer Narrative
H2) device evaluation: h3, h6: the device was not returned for analysis.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.The customer provided a photo for the evaluation.The photo showed an extension set in which the part number could not be identified, and also showed a used sample with a disconnection at the tube to luer joint.The reported issue "break near the connection point" was confirmed.Since the sample complaint was not returned for evaluation, the failure mode cannot be attributed to the manufacturing process.A device history review had no significant findings.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMIITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19660919
• Report Number: 9617604-2024-00563
• Device Sequence Number: 20545141
• Product Code: FPA
• UDI-Device Identifier: 15019517184204
• UDI-Public: (01)15019517184204(17)250712(10)4016507
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K942046
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 07/12/2025
• Device Model Number: 21-7044-24
• Device Catalogue Number: 21-7044-24
• Device Lot Number: 4016507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2020
• 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