MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI OXIMETER ACCESSORIES; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	3043
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 : (b)(6).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.
Event or Problem Description
It was reported the oximetry probe's sensors stopped working within a short period of time.The spo2 values were inconsistent with the patient's condition.The event occurred during patient use and there was no patient harm/adverse event.
Additional Manufacturer Narrative
H3 - device not returned to date.H6 - evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The exact cause could not be determined; however, based on the reported problem, the most probable cause could be improper patient attachment tape use.A device history report (dhr) review could not be performed as the dhr is at the supplier.If the product is returned, the manufacturer will reopen this complaint for further investigation.H3 - device returned to manufacturer: no.
Additional Manufacturer Narrative
D4: updated **udi related data quality updates only**.

• Brand Name: BCI OXIMETER ACCESSORIES
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18384220
• Report Number: 3012307300-2023-12191
• Device Sequence Number: 4196855
• Product Code: DQO
• UDI-Device Identifier: 15019517042542
• UDI-Public: (01)15019517042542(17)310601(10)2116-1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K893877
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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 Model Number: 3043
• Device Catalogue Number: 3043
• Device Lot Number: 21161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 01/25/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/22/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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