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

Device Problems Crack (1135); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2022

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 301645803
• Report Number: 2028807-2022-00016
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 00709078008290
• UDI-Public: 00709078008290
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other