MAUDE Adverse Event Report: HALYARD HEALTH CORPAK-FARRELL,VALVE,DCMPRSNBAG,NA,500ML; DH CPK FARRELL BAG

Model Number	20-4100
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Choking (2464)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
A report was received stating there was a choking hazard event associated with the farrel bags.The reporter was unable to confirm the number of times this event has occurred.The roller clamp ball easily becomes dislodged and can then be replaced.While at home, a clamp became dislodged and was found in the patient's mouth.No additional information was provided.

• Brand Name: CORPAK-FARRELL,VALVE,DCMPRSNBAG,NA,500ML
• Common Device Name: DH CPK FARRELL BAG
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6438643
• Report Number: 3009124963-2017-00008
• Device Sequence Number: 18967274
• Product Code: KNT
• UDI-Device Identifier: 20815149021984
• UDI-Public: 20815149021984
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K853253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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
• Operator of Device: Nurse
• Device Model Number: 20-4100
• Device Catalogue Number: 104573500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/28/2017
• Patient Sequence Number: 1