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

Model Number	2002-7-50
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.D4: the documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 06 nov 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med 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 sun med holdings llc.Sun med 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 sun med holdings complaint database and 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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 3000219639-2024-00122 for the first report.Refer to 3000219639-2024-00124 for the third report.Back pressure was reported, when the tubing was placed on the optiflows and/or trach collars, and leaking around the collar of the tubing where the tubing meets the connector was noted.It was additionally reported, during the event, the patient did not receive the set flow rate; the device was replaced, there was no reported injury.

• Brand Name: SALTER LABS OXYGEN TUBING
• Common Device Name: OXYGEN TUBING WITH 2 STANDARD CONNECTORS (6 MM), 7 (2.1 M)
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20621443
• Report Number: 3000219639-2024-00123
• Device Sequence Number: 7553329
• 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: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 11/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown