MAUDE Adverse Event Report: VENTLAB MEDLINE; RESUS BAG

Model Number CPRM1116M

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The affected product had a patient valve which is used on many resus products.Thirteen valves were removed from inventory and tested one at a time with a k-resin mask.The valve was held in one hand and the mask was held in the other.Every reasonable attempt was made to break the patient valve off.None of the valves broke.The customer returned one affected device in a biohazard bag.The patient port and the mask were missing.The patient valve did not exhibit any damage even though the patient port was missing.This affected device utilized a patient valve (p/n 402114 lot 161000117) and mask (p/n 205104 lot 16090064).The patient valve was received on 11/29/2016 which means it had a pet patient port and the improved c-ring design.The mask was received on 10/13/2016 which means it had a k-resin cone.To the investigator's knowledge, this is the first complaint for a patient port detaching with this combination of materials.

Event Description

The customer alleges "the patient port separated from the rest of the bag." no other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: RESUS BAG
• Manufacturer (Section D): VENTLAB; 2710 northridge dr.; suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB; 2710 northridge dr.; suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 6674072
• MDR Text Key: 78700768
• Report Number: 2246980-2017-00022
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1116M
• Device Lot Number: 308026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1