MAUDE Adverse Event Report: CAREFUSION RESUS BAG ADULT MANUAL 6/CS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 2K8004

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

Upper neck base of bag fell/tore off.Additional information received on (b)(4) 2014 from (b)(6): in this situation, a nurse was using the product on a patient and the neck came off the resus bag, in addition, the reservoir bag came off and tore.Customer stated that the bag was replaced and no patient harm or injury reported.Customer stated sample was tossed.Representative sample being sent.

Manufacturer Narrative

(b)(4).The actual device used during this report is not available for evaluation.The customer sent in another 2k8004 resuscitation bag for evaluation.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

Cfn-2014-681.Results of investigation: unfortunately, the sample was not available for evaluation.However, a representative sample from lot 0000585933 was sent for evaluation.Per visual inspection, the sample was received without a mask.The (elbow-fitting) component was inspected and was found within specification, no detaching conditions were observed.Unfortunately, a lot number of the product in this incident was not available.Therefore, a review of the internal production records could not be performed.However, lot 0000585933 was taken from the sample received and no issues were observed during the production record review.After the manufacturing process review, it was observed that personnel are performing the assembly in accordance to procedure: the operator takes connector (elbow-fitting) component and assembles this by press to the elbow end.Based on the investigation, at this time it¿s not possible to determine a root cause for the elbow (neck) coming off the bag since the representative sample showed no defects.Carefusion will continue to monitor and trend this report.

• Brand Name: RESUS BAG ADULT MANUAL 6/CS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• 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 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3667980
• MDR Text Key: 4321236
• Report Number: 8030673-2014-00103
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2K8004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• 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