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

Catalog Number 3043

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone number: (b)(6).E2: incorrect due to system limitations.E2 - correct response: n - initial reporter is quality specialist, non-healthcare professional.H3 - other: device has not been returned for investigation.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 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 sample is available for evaluation.The event occurred during patient use.There was no patient harm/adverse event.

Manufacturer Narrative

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.

• Brand Name: BCI OXIMETER ACCESSORIES
• Type of Device: 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: 18380121
• MDR Text Key: 331381924
• Report Number: 3012307300-2023-12161
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 15019517042542
• UDI-Public: (01)15019517042542(17)310401(10)2105-1
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K893877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3043
• Device Lot Number: 2105-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1