MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; 96" ADULT EXP,GSE,PAR WYE,(2)BV,LG.MASK,3LF BAG,3LF BAG,10'X.050" MM GSL,

Model Number	9677
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Splits/cracks in tubing the crns extended the tubing after induction and an obvious break in the tubing occurred in two places.This was a serious situation because of the patient's comorbidities and the concern for ett in esophagus.
Additional Manufacturer Narrative
The splitting of the tube caused the patient to re-intubated.Base on the reported information the criteria for reporting an adverse event has been met.
Event or Problem Description
Splits/cracks in tubing the crns extended the tubing after induction and an obvious break in the tubing occurred in two places.This was a serious situation because of the patient's comorbidities and the concern for ett in esophagus.
Additional Manufacturer Narrative
The splitting of the tube caused the patient to re-intubated.Base on the reported information the criteria for reporting an adverse event has been met.Complaint confirmed with the photos provided in the related complaints and returned goods.The root cause was determined to be that the hose that feeds one of the plastic resins into the blender was not properly connected.This resulted in an incorrect ratio of resins, leading to the tubing being more rigid and more likely to crack.Lab results confirmed that tubing manufactured after the hose was fixed was the correct ratio of plastic resins.We completed a health hazard evaluation as part of the risk assessment.The risk assessment performed with rma-20030 indicated a severity of 9.We initiated capa-00495 to address this issue.We reviewed the complaint history in our quality management system related to the affected product for the 24 months preceding the earliest complaint received.We did not receive any complaint for this product preceding complaint 07496.Also, we analyzed the frequency of complaints we have received for the circuit product family.There is no trending issue for the circuit product family.We emailed resolution to the customer.

• Brand Name: WESTMED LLC
• Common Device Name: 96" ADULT EXP,GSE,PAR WYE,(2)BV,LG.MASK,3LF BAG,3LF BAG,10'X.050" MM GSL,
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 14843216
• Report Number: 2028807-2022-00016
• Device Sequence Number: 17533395
• Product Code: OFP
• UDI-Device Identifier: 00709078008290
• UDI-Public: 00709078008290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 9677
• Device Catalogue Number: 9677
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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