MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW; RESUS BAG

Model Number AF5140MB

Device Problems Break (1069); Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Manufacturer Narrative

The material composition of the resus bag and the drawstring bag are too similar causing the two products to "stick" together when the user tries to remove the resus bag from the drawstring bag.A non-conformance has been opened to quarantine all of the unused drawstring bags and another non-conformance has been opened to performed a wholesale rework of resus bags which includes the replacement of the drawstring bags.

Event Description

The customer alleges "product was broken while being removed from the packaging.The packaging was sticky and the product was difficult to remove." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB LLC.; 2710 northridgedr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598350
• MDR Report Key: 5994946
• MDR Text Key: 56542393
• Report Number: 2246980-2016-00051
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K012842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MB
• Device Lot Number: 305544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1