MAUDE Adverse Event Report: CAREFUSION NEEDLE COAXIAL INTRODUCER 19G X10CM; GUIDE, NEEDLE, SURGICAL

Model Number PP1910

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon carefusion's investigation a follow up emdr submission will be submitted.

Event Description

Customer stated per email we just had an introducer, 19g 10cm, break off in a patient during a procedure.October 15, 2015 - additional information; a presacral mass biopsy was being performed and was completed.The remaining needle was extracted.To the customers knowledge, the patient did not require additional intervention and has no further complaints post procedure.

Manufacturer Narrative

One (1) sample was received for evaluation.Failure mode could be confirmed since during visual analysis it was noticed that the needle was broke into three pieces.A review of the internal manufacturing device record and raw material history files for the reported lot #0000784673 which was manufactured on (b)(6) 2015 was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.No adverse trend has been detected for the reported failure mode.Most probable root cause could not be determined since no issues were found during the applicable manufacturing, packaging and inspection processes that can relate personnel, material or method with the reported failure.No action has been proposed since no issues were found during evaluation.The reported failure is being tracked.

• Brand Name: NEEDLE COAXIAL INTRODUCER 19G X10CM
• Type of Device: GUIDE, NEEDLE, SURGICAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 203 LTD; zona franca las americas; km 22 e-1; santo domingo ; DR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5177411
• MDR Text Key: 29245016
• Report Number: 9680904-2015-00066
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PP1910
• Device Lot Number: 0000784673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1