MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE DISPOSABLE UNIVERSAL OXYGEN NUT AND NIPPLE CONNECTION; CANNULA, NASAL, OXYGEN

Model Number	CONNECTOR NUT/NIPPLE UNIV F/O2
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the the 001840 - airlife disposable universal oxygen nut and nipple connection has a sharp edge that should not be present.This caused palm laceration to a staff member.Also, the defect was found to be present in multiple pieces (25).They were removed.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Based on the investigation carried out and per picture and physical sample received, reported defect is confirmed.Manufacturing personnel may be related to the reported defect since the work instruction indicates that personnel must remove the plastic remnant correctly using tweezers in case the remnant is bigger than the permit.If this action is not properly followed, defects such as the one reported in this complaint could occur.Therefore, the root cause was confirmed.In order to detect any issue related to the reported defect during its manufacturing, the device history record should be reviewed.Unfortunately, since the lot number was not provided, we could not identify and locate the respective dhr.

• Brand Name: AIRLIFE DISPOSABLE UNIVERSAL OXYGEN NUT AND NIPPLE CONNECTION
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16921903
• Report Number: 8030673-2023-00318
• Device Sequence Number: 12492955
• Product Code: CAT
• UDI-Device Identifier: 10190752117105
• UDI-Public: (01)10190752117105
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CONNECTOR NUT/NIPPLE UNIV F/O2
• Device Catalogue Number: 001840
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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