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

Catalog Number	3043
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 reporter phone: (b)(6).E2: incorrect due to system limitations.E2 correct response: n - initial reporter was a quality specialist.H3 - other: device not returned to manufacturer.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 reportable information becomes available.
Event or Problem Description
It was reported that there was a failure during the read.There was an incorrect read of the spo2.The type y neonatal oximetry 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 when the failure was detected, however there was no one harmed as result of the event.
Additional Manufacturer Narrative
Product was not returned, and no photographic evidence provided to aid in this investigation.As a result, product evaluation and problem confirmation cannot be performed.The exact cause could not be determined; however, based on the reported problem, the most probable cause could be improper patient attachment tape use.Item is a purchased finished good, the device history record (dhr) is at the supplier and not readily available for review.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
D4: udi 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: 18360094
• Report Number: 3012307300-2023-12116
• Device Sequence Number: 15434327
• Product Code: DQO
• UDI-Device Identifier: 15019517042542
• UDI-Public: (01)15019517042542(11)210819(10)2122-1
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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 Catalogue Number: 3043
• Device Lot Number: 2122-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 01/24/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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
• Patient Sex: Unknown