MAUDE Adverse Event Report: SALTER LABS N/A; OXYGEN TUBING WITH 2 STANDARD CONNECTORS (6 MM), 7' (2.1 M)

Model Number	2002-7-50
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: tubing.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 15 nov 2024, has been included in the health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc., has no independent knowledge of the event reported, but is relaying the information, that was provided by the user facility, where the incident occurred.This product incident is documented in the sunmed holdings complaint database.And is identified as (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission, that a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
When tubing is placed on optiflows or trach collars, there is back pressure and they leak around the "collar" of the tubing, where the tubing meets the connector.And therefore, the patient is not getting the set flow rate.
Event or Problem Description
When tubing is placed on optiflows or trach collars there is back pressure and they leak around the "collar" of the tubing, where the tubing meets the connector, and therefore the patient is not getting the set flow rate.
Additional Manufacturer Narrative
H6: tubing the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 15 nov 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided byairlife 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 airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint reported that the unit "patient is not getting the set flow rate." an investigation was conducted, and it was determined that no patients were affected.Since no video evidence was provided, the complaint could not be confirmed.However, the probable cause may have been due to the tubing may have not been firmly or correctly attached, it may have not formed a tight seal, allowing air to escape and reducing the flow rate delivered to the patient.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first complaint reported for part number 2002-7-50 for "insufficient flow" failure mode.There were nine complaints reported for part number 2002-7-50 during the same timeframe related to different failure modes.A resolution was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: N/A
• Common Device Name: OXYGEN TUBING WITH 2 STANDARD CONNECTORS (6 MM), 7' (2.1 M)
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20700854
• Report Number: 3000219639-2024-00097
• Device Sequence Number: 6583344
• Product Code: BYX
• UDI-Device Identifier: 10607411200011
• UDI-Public: (01)10607411200011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 2002-7-50
• Device Catalogue Number: 2002-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown