MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC; BIOPSY NEEDLE KIT

Model Number BCTM3411

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted upon completion of investigation.(b)(4).

Event Description

Customer reported verbally via telephone call that the plastic hub broke and exposed the metal tip which jammed into the physician's hand.The patient being treated has (b)(6), it did not appear that the skin of the doctor was broken but they are performing a series of tests to be certain.Additional information received (b)(6) 2017: please add to your notes the patient is positive for (b)(6) as well as (b)(6).There was no impact to the patient as a result of this incident.The physician is a (b)(6) male.His initials are (b)(6).No other medical intervention was done to the physician beyond lab testing.Additional information received (b)(6) 2017: medical intervention initial (b)(6) testing as well as follow up testing on pathologist in coming months user harm it is yet to be determined if pathologist who was using device has been infected with (b)(6).Description of event pathologist was collecting bone marrow sample.As he was applying pressure on the acquisition cradle, the white plastic hub slid down the cradle exposing the metal tip.This metal tip went into the palm of the pathologist's hand.We don't think the skin was broken, but as stated above follow-up testing is being performed.

Manufacturer Narrative

(b)(4) follow up emdr submission for device evaluation.One cradle was returned for analysis.Visual inspection confirmed that the hub of the cradle had been pushed down, exposing the top tip of the cradle.Therefore the reported defect was confirmed.Additional inspection confirmed that sufficient adhesive was present on the hub/cradle interface.Pressure was applied to the hub in order to further advance it down the cradle, and no sources of the issue were identified.A device history record review was performed for lot 0000980820.No issues were found, indicating that manufacturing procedures were properly performed, and subsequent quality inspections were passed.Visual inspection of the returned cradle confirmed that the hub had been pushed down, exposing the top of the cradle cannula.Adequate adhesive on the hub was observed during sample evaluation, and further exposure of the cannula did not reveal other potential causes for the defect.Therefore, a root cause could not be established.The manufacturer is to be made aware of the complaint by quality notification, which has been sent.

• Brand Name: JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC
• Type of Device: BIOPSY NEEDLE KIT
• 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: 6232685
• MDR Text Key: 64171261
• Report Number: 1625685-2017-00270
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913306
• 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,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCTM3411
• Device Lot Number: 0000980820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR