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

Model Number 2K8036

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2014

Event Type  Injury  

Event Description

Sales rep reported via telephone:oxygen tubing becomes disconnected from bottom of resuscitation bag, and falls out.During patient use,of which resulted in the clinician to replace with another bag.No patient harm reported as bags were replaced.

Manufacturer Narrative

(b)(4).Unfortunately, no sample was received for evaluation.No issues were found during the review of internal production records for the lot indicated that could result in the reported condition.Based on the investigation, the most probable cause for the issue reported is due to manufacturing personnel not following the applicable manufacturing process and did not correctly assemble the tubing in the connector.To prevent future occurrences, the following actions have been implemented: applicable personnel were notified of this issue and re-trained on the manufacturing procedure.Work instructions will be modified to add visual aids with a more clear acceptable/reject able criteria for oxygen tubing assembly to connector.Carefusion will continue to monitor and trend this issue.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).Additional investigation result: additional closed samples received from the same lot.11 of the samples failed the hand pull test on the tubing to the adaptor area.In addition, the additional samples were dimensionally inspected and found that p/n 58-1831 was outside specification range.Based on the investigation, the most probable cause for the issue reported is due to manufacturing personnel not following the applicable manufacturing process and did not correctly assemble the tubing in the connector.To prevent future occurrences, the following actions have been implemented: applicable personnel were notified of this issue and re-trained on the manufacturing procedure.Work instructions will be modified to add visual aids with a more clear acceptable/reject able criteria for oxygen tubing assembly to connector.Additional samples will be taken by production every two hours to perform dimensional inspection using a fixture.Carefusion will continue to monitor and trend this issue.

• Brand Name: RESUS BAG ADULT W/PEEP 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 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4149710
• MDR Text Key: 4912975
• Report Number: 8030673-2014-00128
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2K8036
• Device Lot Number: 0000321144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• 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
• Patient Outcome(s): Required Intervention