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 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 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.

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.

• 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: 18359978
• MDR Text Key: 331214436
• Report Number: 3012307300-2023-12111
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 15019517042542
• UDI-Public: (01)15019517042542(11)210819(17)310801(10)2122-1
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 2122-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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