MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 15GA - TIN3015; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that needle broke in half while in patient's bone.Verbatim: bone marrow needle broke in half at the handle side while in patient¿s bone.The patient was sedated for the procedure, no additional bleeding.Team had to use needle extractor to remove.Patient required an additional bone marrow for samples.Additional stress on patient and family as they wait bone marrow results on top of the occurrence.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that needle broke in half while in patient's bone.Verbatim: bone marrow needle broke in half at the handle side while in patient¿s bone.The patient was sedated for the procedure, no additional bleeding.Team had to use needle extractor to remove.Patient required an additional bone marrow for samples.Additional stress on patient and family as they wait bone marrow results on top of the occurrence.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos samples were provided to our quality team for investigation.Through visual inspection, it is observed that cannula was broken and showed signs of bending which points to excess force being applied during insertion or material/design issue; therefore, the reported failure mode broken needle was confirmed.A review of the internal manufacturing device records and raw material history files for the reported possible lots 0001378293, 0001389688, 0001390329 were performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Two reported incidents of this failure mode over the last year and no knowledge of how the procedure was performed, the most probable root cause is incorrect use by the end user.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 15GA - TIN3015
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13551176
• Report Number: 1625685-2022-00033
• Device Sequence Number: 5051302
• Product Code: LWE
• UDI-Device Identifier: 10885403043796
• UDI-Public: (01)10885403043796
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown