MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BIOPSY 15G X 100MM DISP; TRAY, SURGICAL, NEEDLE

Model Number	SN1015X
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
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 customer received sterile product that has been sealed with a strand of human hair.Verbatim: also, we received sterile product that has been sealed with a strand of human hair.Ref (b)(4), lot 0001224605.
Event or Problem Description
It was reported that customer received sterile product that has been sealed with a strand of human hair.Verbatim: also, we received sterile product that has been sealed with a strand of human hair.Please provide additional details in regard to the issue? prior to opening, it was discovered hair to be in the package with product.Was there any patient impact or delay in treatment? no, the product is still in the package.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one physical sample was received by our quality team for investigation.Upon visual inspection of the sample, the foreign matter was observed in the packaging; 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 0001224605 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 information provided, a probable root cause was manufacturing related.Awareness training was conducted.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.One physical sample was received by our quality team for investigation.Upon visual inspection of the sample, the foreign matter was observed in the packaging; 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 0001224605 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 information provided, a probable root cause was manufacturing related.Awareness training was conducted.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 manufacture narration.

• Brand Name: JAMSHIDI NEEDLE BIOPSY 15G X 100MM DISP
• Common Device Name: TRAY, SURGICAL, 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: 14454703
• Report Number: 1625685-2022-00055
• Device Sequence Number: 17383810
• Product Code: FSH
• UDI-Device Identifier: 10885403076152
• UDI-Public: (01)10885403076152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 03/31/2023
• Device Model Number: SN1015X
• Device Catalogue Number: SN1015X
• Device Lot Number: 0001224605
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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