MAUDE Adverse Event Report: SUNMED LLC SUNMED LLC; GUEDEL PVC SZ4

Model Number 1-1521-04

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Plastic wrap could be a potential choking hazard, could be inhaled or swallowed.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

Pouch is shredding and sticking to the device when opened."anesthesiologists were forced to rapidly remove small pieces of the plastic bag wrap from the oral airway's exterior surface which had shredded loose from the remainder of the plastic bag wrap upon opening.As you can imagine, this is a near emergent situation which requires quick response while continuously evaluating a patient.".

Event Description

Pouch is shredding and sticking to the device when opened."anesthesiologists were forced to rapidly remove small pieces of the plastic bag wrap from the oral airway's exterior surface which had shredded loose from the remainder of the plastic bag wrap upon opening.As you can imagine, this is a near emergent situation which requires quick response while continuously evaluating a patient.".

Manufacturer Narrative

Plastic wrap could be a potential choking hazard, could be inhaled or swallowed.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met complaint history reviewed.There have been no complaints for this issue in the previous 24 months.Complaint is not trending but will continue to be monitored.Returned product was hand sorted for "stickiness" and failure mode was attempted to be recreated.Product was placed in oven at 65c and placed in front of heat gun to melt bag and recreate improper storage conditions.Product was deformed but was able to be opened without issue.Failure mode could not be recreated and therefore complaint could not be confirmed.Risk(ra-47): r1: infectious material present on device - unable to open package aseptically - s=7, o=1, rpn=7.Rpn < 25 therefore risk is acceptable.

• Brand Name: SUNMED LLC
• Type of Device: GUEDEL PVC SZ4
• Manufacturer (Section D): SUNMED LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED LLC; 2710 nothridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13981302
• MDR Text Key: 298235258
• Report Number: 1314417-2022-00012
• Device Sequence Number: 1
• Product Code: CAE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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
• Device Operator: Health Professional
• Device Model Number: 1-1521-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other