MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP; TRAY, SURGICAL, NEEDLE

Model Number DJ4011X

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up submission will be completed upon carefusion's investigation.(b)(4).

Event Description

The needle broke off in the patient and patient had to go to theatre to have needle removed.Provider was using jamshidi and placed the needle in patient's iliac crest but was having trouble getting it out; he had to use force to remove and the handle snapped off.He then used forceps to remove the rest of the needle but it snapped again.Patients current health status is fine and no further intervention needed.

Manufacturer Narrative

(b)(4) follow up emdr submission for device evaluation.One (1) sample from lot #00001001455 was provided for evaluation.Failure mode could be confirmed since the device was broken.A review of the internal manufacturing device record and raw material history files for the reported lot number 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.Lot #0001001455 was manufactured on 26-sep-2016.Most probable cause of failure mode reported could be related with material provided from bd mannford.A scar (supplier corrective action request) has been issue to the supplier (bd-mannford).This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 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; zona franca las americas; santo domingo ; DR
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6644301
• MDR Text Key: 77656727
• Report Number: 9680904-2017-00110
• Device Sequence Number: 1
• Product Code: FSH
• Combination Product (y/n): N
• PMA/PMN Number: K813338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DJ4011X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• 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): Required Intervention