MAUDE Adverse Event Report: CAREFUSION ADAPTER MASK INTIB 22MMX15MM 50/CS; CONNECTOR, AIRWAY (EXTENSION)

Model Number 001820-A

Device Problems Material Integrity Problem (2978); Packaging Problem (3007)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission- the device was received for evaluation and the investigation is in process currently.The customer was unable to provide the lot number for the product as the packaging was thrown away.The failure reported was found prior to patient use, so there was no patient impact or harm.Once the investigation is complete or if any additional information is received, a follow up mdr will be submitted.

Event Description

Customer stated via email: this was noticed out of the package the center ring did not have it "punched" out so there was no pass thru in the adapter.He could not tell due to the packaging if it is a lot number issue or not.Reported item was not being used on patient.States, "no patient harm.Due to being placed on the equipment prior to being used the packaging was not kept." unable to provide a lot number.

• Brand Name: ADAPTER MASK INTIB 22MMX15MM 50/CS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5227073
• MDR Text Key: 31525197
• Report Number: 8030673-2015-00142
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: 001820-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1