MAUDE Adverse Event Report: COOK INC CHIBA BIOPSY NEEDLE; DEVICE, PERCUTANEOUS, BIOPSY

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: (b)(6).G4, pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that during the inspection upon receipt of the chiba biopsy needle, a "hair" was identified within the sealed/unopened package.The product did not make patient contact.
Additional Manufacturer Narrative
Investigation ¿ evaluation on 16jun2023, (b)(6) ctr (united states) reported an event involving a chiba biopsy needle (rpn: dchn-21.20.0, lot: 14437747) that occurred the same day.The customer stated that they found a hair-like fiber in the sealed/unopened package.The fiber was discovered when the product was received in materials management.There was no patient or procedure involved or affected.Reviews of the documentation, including the complaint history, device history record, instruction for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One sealed device was returned for evaluation.A hair-like fiber was observed on the protector tube of the device within the sealed packaging.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) identified process steps to ensure that nonconforming material does not leave the house.A review of the device history record (dhr) for lot 14437747 found one relevant nonconformance, in which the devices were re-worked, and 100% inspected per quality control.It should be noted that there were no other complaints associated with the final product lot number.An expanded dhr was performed for additional lots with the same rpn manufactured within the same month.Although one relevant nonconformance was identified, all affected devices were re-worked and 100% inspected per quality control.No other complaints were associated with the lot numbers included in the expanded search.Cook was unable to review product labeling, as this product is not supplied with an ifu pamphlet.Evidence gathered from the device failure analysis indicated that the product was manufactured out of specification.However, a review of the dmr and dhr suggests that there are no additional nonconforming devices in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was determined that a manufacturing and quality control deficiency contributed to the event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: CHIBA BIOPSY NEEDLE
• Common Device Name: DEVICE, PERCUTANEOUS, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17195130
• Report Number: 1820334-2023-00809
• Device Sequence Number: 7461898
• Product Code: MJG
• UDI-Device Identifier: 00827002008953
• UDI-Public: (01)00827002008953(17)261227(10)14437747
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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
• Device Model Number: N/A
• Device Catalogue Number: DCHN-21-20.0
• Device Lot Number: 14437747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown