MAUDE Adverse Event Report: COOK INC KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Catalog Number	DKBL-20-11.0-A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported during a breast localization procedure, a hair like "fibre" was found in an unopened kopans modified breast lesion localization needle pouch.Another device was used in the procedure.As reported, the device did not make patient contact; therefore, this device issue did not cause an adverse effects to the patient.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a hair-like fiber within the packaging.The seals of the package were still intact.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications and no gaps in production or processing controls were noted.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause was able to be determined.This failure is likely to be manufacturing related, specifically due to operator error, as the device was not rejected per the appropriate quality control procedures.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7693314
• Report Number: 1820334-2018-02086
• Device Sequence Number: 848576
• Product Code: MIJ
• UDI-Device Identifier: 00827002037953
• UDI-Public: (01)00827002037953(17)201229(10)NS6487651
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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 Expiration Date: 12/29/2020
• Device Catalogue Number: DKBL-20-11.0-A
• Device Lot Number: NS6487651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1