MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 6FR X 16CM; NEEDLE, CATHETER

Model Number PIG1260T

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: leak.Patient problem code: no consequences or impact to patient.

Event Description

Leak it was reported via email: air is leaking from the catheter.Patient impact unknown.Additional information received 29march2017: did it occur during patient use? if yes, was there any patient injury or intervention? yes, but no patient injury.Do you have a sample that you would like to return for evaluation? if yes: no, we didn't keep the product.

• Brand Name: SAFE-T-CENTESIS TRAY 6FR X 16CM
• Type of Device: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6460026
• MDR Text Key: 72100322
• Report Number: 1625685-2017-00282
• Device Sequence Number: 1
• Product Code: GCB
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIG1260T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1