MAUDE Adverse Event Report: AMCOR FLEXIBLES HEALTHCARE AMCOR FLEXIBLES; BAG VENTED 24X24 N/S

Model Number 111197B

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Date 09/08/2020

Event Type  malfunction  

Event Description

White filter circle on vented bag not cut and placed properly.Exposed inner pack was noted.Pack unsterile.No harm to patient, and not delay of case.Pack removed from field and replaced.This was found on roi cps, llc minor pack 880032019-lot 78487s.

• Brand Name: AMCOR FLEXIBLES
• Type of Device: BAG VENTED 24X24 N/S
• Manufacturer (Section D): AMCOR FLEXIBLES HEALTHCARE; 1919 butterfield rd; mundelein, il
• Manufacturer (Section G): AMCOR FELXIBLES HEALTHCARE; 1919 butterfield rd; mundelein, il
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, mo ; 7303937
• MDR Report Key: 10560840
• MDR Text Key: 209030855
• Report Number: 3014527682-2020-00015
• Device Sequence Number: 1
• Product Code: FRG
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111197B
• Device Lot Number: 961403
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: No
• 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