MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, STRAP KIT, FLUID DELIVERY LINE; FLUID DELIVERY LINES

Model Number	73490
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that when arctic sun device was checked to be delivered, there was a burr left in the button of the attached strap kit and the fastener did not fit.Per additional information received via follow-up on (b)(6)2023, it was reported that issue would be resolved by replacing it with a new one.
Event or Problem Description
It was reported that when arctic sun device was checked to be delivered, there was a burr left in the button of the attached strap kit and the fastener did not fit.Per additional information received via follow-up on 25-jan-2023, it was reported that issue would be resolved by replacing it with a new one.
Additional Manufacturer Narrative
Per investigational findings, bd has determined that this mdr as not reportable as the reported event was confirmed as plastic deformation.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, STRAP KIT, FLUID DELIVERY LINE
• Common Device Name: FLUID DELIVERY LINES
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16264310
• Report Number: 1018233-2023-00413
• Device Sequence Number: 4402970
• Product Code: DWJ
• UDI-Device Identifier: 00801741080289
• UDI-Public: (01)00801741080289
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 73490
• Device Catalogue Number: 734-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown