MAUDE Adverse Event Report: VYARRIE MEDICAL AIRLIFE, TRI-FLO SUCTION CATH-N-GLOVE KIT

Model Number	4893T
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Malfunction
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 8030673-2025-00007 for the first report.It was reported; the suction catheter was contaminated with a [unknown] black material.Upon discovery, a new closed suction system was placed.[the discovery may have lead to] a delay in suctioning.It was additionally reported, the patient was positive for serratia (water bacteria) in their endotracheal tube.At the time of the report, the patient was vented, and in isolation for positive cultures for serratia.
Additional Manufacturer Narrative
The actual sample from the reported event was returned and processed for evaluation.The device history record for lot 0004247691 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 feb 2025 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 (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.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.Visual examination of the returned product determined the product was unacceptable due to black material seen on the product.The reported event could be confirmed as reported, the root cause was determined to be material related.The device history record for lot 0004247691 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 mar 2025 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 (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 two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 8030673-2025-00007 for the first report it was reported, the suction catheter was contaminated with a [unknown] black material.Upon discovery, a new closed suction system was placed.[the discovery may have lead to] a delay in suctioning.It was additionally reported, the patient was positive for serratia (water bacteria) in their endotracheal tube.At the time of the report, the patient was vented, and in isolation for positive cultures for serratia.

• Brand Name: AIRLIFE, TRI-FLO SUCTION CATH-N-GLOVE KIT
• Common Device Name: TRI-FLO SUCTION CATH-N-GLOVE KIT
• Manufacturer (Section D): VYARRIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california
• Manufacturer (Section G): VYARRIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mexico ; MX
• Manufacturer Contact: racheal cooper ; 2710 northridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 21329455
• Report Number: 8030673-2025-00008
• Device Sequence Number: 8485143
• Product Code: OFO
• UDI-Device Identifier: 10190752148956
• UDI-Public: (01)10190752148956(10)0004247691(11)230502(17)260503
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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 Expiration Date: 05/03/2026
• Device Model Number: 4893T
• Device Catalogue Number: 4893T
• Device Lot Number: 0004247691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown