MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP; TRAY, SURGICAL, NEEDLE

Model Number BAK4511

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up emdr will be submitted upon carefusion's investigation.(b)(4).

Event Description

While doing core aspiration, (it was reported) the needle broke off in the patient's iliac crest, requiring her to go to the hospital for (surgical consult) for (possible) removal of the needle.Additional information received; hospital stated they did not see the needle after mri was performed and nothing was seen.Physician reported there was no difficulty entering the iliac crest.No further intervention needed at this point.Procedure was not repeated.

Manufacturer Narrative

(b)(4) carefusion investigation: a device history record review was completed for lot 0001062525.No issues were found, indicating that manufacturing procedures were properly followed, and subsequent quality inspections were passed.A failure could not be confirmed as no sample was available for analysis.The device history record indicated that the jamshidi bone marrow tray was built according to procedure, and quality inspections for the device were passed.Therefore, a root cause could not be identified.Based on the lack of a definitive root cause, no corrective or preventive actions were identified for the reported failure mode.This complaint will be added to the complaint trending system and will be monitored for future occurrences.

• Brand Name: JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
• Type of Device: TRAY, SURGICAL, NEEDLE
• 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: 6581296
• MDR Text Key: 75858108
• Report Number: 1625685-2017-00295
• Device Sequence Number: 1
• Product Code: FSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BAK4511
• Device Lot Number: 0001062525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR