MAUDE Adverse Event Report: VYAIRE MEDICAL INC AIRLIFE¿ STERILE 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP 110 ML; CATHETER AND TIP, SUCTION

Model Number	SALINE 0.9% DUALTOP PLAST BT 110ML 25/CS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the three bottles of saline 0.9% dualtop plast bt 110ml 25/cs are leaking.The seam on each bottle is defective and if the customer moves a bit, the bottle spray from the nozzle.Furthermore, there is no patient associated with the said event.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h6 and h10.Result of investigation: the device was not returned for product evaluation.Review of retained samples in the warehouse was performed, and no leaks, cracks, or any other type of defect were detected.Review of the batch master record and background research revealed a previous event of high rejection due to head cracking during the conditioning of lot t22k23.It was found that the dosing mandrel directly affects the amount of plastic in the bottle head, so head cracking may occur if it is found to be incorrectly positioned during solution dosing.Root cause was then determined to be machinery/failure in the control system, derived from the fact that the presence of head cracking in the conditioning stage of the packaged product is due to the height adjustments of the dosing mandrel and there are no control parameters that allow an optimal operation reducing the presence of defective due to head cracking during packaging and after sterilization.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ STERILE 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP 110 ML
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA ; carretera san isidro mazatepec; 7000 tlajomulco de zúñiga; jalisco 45645 ; MX 45645
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17232647
• Report Number: 3015973929-2023-00003
• Device Sequence Number: 12564549
• Product Code: JOL
• UDI-Device Identifier: 10190752130401
• UDI-Public: (01)10190752130401(10)T22K23
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: SALINE 0.9% DUALTOP PLAST BT 110ML 25/CS
• Device Catalogue Number: AL4109
• Device Lot Number: T22K23
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown