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	09/21/2017
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 international customer reported that, during an pre-use inspection of the chiba biopsy needle, an unidentified particle was discovered in the primary package.The customer confirmed that the device never made contact with any patient; accordingly, no adverse events occurred.The product is reportedly unavailable for return.
Additional Manufacturer Narrative
Investigation summary: a review of the device history record, specifications, quality control and documentation of the device were conducted during the investigation.A device was not returned.Five photos showing the foreign matter within the packaging were provided by the customer.Additionally, a document based investigation evaluation was performed.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, the actual root cause of this failure is manufacturing related, as evidenced by the photos sent by the customer.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor for similar complaints.

• Brand Name: CHIBA BIOPSY NEEDLE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6918053
• Report Number: 1820334-2017-03442
• Device Sequence Number: 1354677
• Product Code: KNW
• UDI-Device Identifier: 00827002000124
• UDI-Public: (01)00827002000124(17)220110(10)7578046
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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-22-15.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1