MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (INFANT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1601-7
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: o2 cannulas.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 03 jan 2025 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 airlife.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 an airlife product is defective or causes serious injury.
Event or Problem Description
1 section from nasal prong connection point broken/disconnected, replaced prongs with desired effect noted.It was reported that the patient experienced oxygen desaturation, which was resolved by replacing the nasal cannula & caused a delay in care.Additionally, if the incident had not been addressed, the patient could have been at risk of serious harm or injury due to the decreasing oxygen levels caused by a leak in the oxygen tubing connections.
Event or Problem Description
1 section from nasal prong connection point broken/disconnected, replaced prongs with desired effect noted.It was reported that the patient experienced oxygen desaturation, which was resolved by replacing the nasal cannula & caused a delay in care.Additionally, if the incident had not been addressed, the patient could have been at risk of serious harm or injury due to the decreasing oxygen levels caused by a leak in the oxygen tubing connections.
Additional Manufacturer Narrative
H6: o2 cannulas.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 03 jan 2025 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 airlife.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 (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 an airlife product is defective or causes serious injury.The complaint reported an issue of "1 section from nasal prong connection point broken/disconnected, replaced prongs with desired effect noted." an investigation reported that the patient experienced oxygen desaturation, which was resolved by replacing the nasal cannula & caused a delay in care.Additionally, if the incident had not been addressed, the patient could have been at risk of serious harm or injury due to the decreasing oxygen levels caused by a leak in the oxygen tubing connections.The complaint photo was unclear but adequately showed some form of damage to the product.The root cause may be attributed to handling prior to the customer's use of the product.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 fourth complaint reported for part number 1601-7-50 for "bond joint separation/disconnection." there were three other complaints reported for part number 1601-7-50 during the same timeframe related to different failure modes.No additional complaints were reported for part number 13300 during the same timeframe.

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (INFANT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE
• 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: 21074744
• Report Number: 3000219639-2025-00003
• Device Sequence Number: 8428340
• Product Code: CAT
• UDI-Device Identifier: 00607411100383
• UDI-Public: (01)00607411100383
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 1601-7
• Device Catalogue Number: 1601-7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown