MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BIOPSY 16G X 70MM DISP; INSTRUMENT, BIOPSY

Model Number	SN7016X
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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.
Event or Problem Description
Material no: sn7016x batch no: 0001372706.It was reported that: customer received box(es) with differing expiration dates event description per attached email states: the customer below called me earlier regarding item sn7016x and it having 2 expiration dates for the same lot # 0001372706.Please see the pictures below of the label and the packaging.The system shows 6-30-25 for the expiration date which is on the box so he wants to confirm if you can send a letter stating that is the true expiration date or do they need to open a product complaint? questions/inquiries: complaint rationale: based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿ appendix 1 - complaint determination tree ¿ (b)(4).
Additional Manufacturer Narrative
One hundred twenty (120) samples were returned for evaluation and the reported failure mode ¿incorrect expiration date¿ was confirmed.The expiration date on the tyvek pouch is 2020-07-20 and the carton expiration date was 2025-06-30.Based on the complaint investigation, potential contributions were identified from both manufacturing personnel and processes.The most probable root cause is that manufacturing personnel and processes for label verification did not properly identify the incorrect expiration date that was printed on tyvek pouch.Capa has been initiated to address incorrectly labeled expiration dating issues.All applicable manufacturing associates will also receive awareness training.This complaint will be entered into the complaint management system and will be tracked and trended through the quality data analysis process for future occurrences.
Event or Problem Description
Material no: sn (b)(6); batch no: 0001372706.It was reported that: customer received box(es) with differing expiration dates.Event description per attached email states: the customer below called me earlier regarding item sn (b)(6) and it having 2 expiration dates for the same lot # 0001372706.Please see the pictures below of the label and the packaging.The system shows 6-30-25 for the expiration date which is on the box so he wants to confirm if you can send a letter stating that is the true expiration date or do they need to open a product complaint? questions/inquiries: complaint rationale: based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿ appendix 1-complaint determination tree ¿ (nassc-rcc-001).

• Brand Name: JAMSHIDI NEEDLE BIOPSY 16G X 70MM DISP
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11227515
• Report Number: 1625685-2021-00007
• Device Sequence Number: 3711415
• Product Code: KNW
• UDI-Device Identifier: 10885403076206
• UDI-Public: (01)10885403076206
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other,us
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 06/30/2025
• Device Model Number: SN7016X
• Device Catalogue Number: SN7016X
• Device Lot Number: 0001372706
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 05/06/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1