MAUDE Adverse Event Report: COOK INC CHIBA BIOPSY NEEDLE

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: mjg.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that, during an inspection of the chiba biopsy needle which occurred prior to use, a hair was visible through the product packaging.The package was reportedly not used on a patient; accordingly, no patient adverse events occurred.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the device was conducted during the investigation.One device was returned opened and unused.A visual examination noted a black, free floating single strand of fiber inside the sterile packaging.No other defects were noted in the packaging.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the packaging was visually inspected by quality control and no notable gaps in production or processing controls were identified.The risk specification for this product includes the failure mode for packaging not keeping the device sterile and bioburden on device due to environmental contamination and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history record was reviewed and no non-conformances were noted with lot 7722541.A search of our complaint records indicates that this is the only complaint associated to the complaint lot 7722541.The complaint has been confirmed based on customer testimony and examination of the returned device.The root cause of this event is manufacturing related - foreign matter.Per the conclusion of the risk assessment for foreign matter, no risk mitigating activity is required at this time.We have notified the appropriate personnel and will continue to monitor for similar events.

• Brand Name: CHIBA BIOPSY NEEDLE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6918157
• Report Number: 1820334-2017-03438
• Device Sequence Number: 13709653
• Product Code: KNW
• UDI-Device Identifier: 00827002039544
• UDI-Public: (01)00827002039544(17)220302(10)7722541
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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 Model Number: N/A
• Device Catalogue Number: DCHN-18-15.0-U
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1