MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4; BIOPSY NEEDLE

Model Number	TJC4011
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The product has a hair inside its package, the issue was noticed by distributor at the time of delivering it to customer.
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
The product has a hair inside its package, the issue was noticed by distributor at the time of delivering it to customer.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos¿ samples were received by our quality team for investigation.Upon visual inspection, it was observed that the hair inside package therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001398752 was 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.Based on the available information we are not able to identify a root cause at this time.Manufacturing personnel have been notified of this incident and additional training was provided.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer here.

• Brand Name: JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4
• Common Device Name: BIOPSY NEEDLE
• 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: 13535499
• Report Number: 1625685-2022-00029
• Device Sequence Number: 20061234
• Product Code: FCG
• UDI-Device Identifier: 10885403044052
• UDI-Public: (01)10885403044052
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K913306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: TJC4011
• Device Catalogue Number: TJC4011
• Device Lot Number: 0001398752
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/01/2022
• 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