MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number	G00003
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = 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, there was a foreign object in the one-part percutaneous entry needle's packaging.This device did not make patient contact.
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, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the device was opened, and there was an unknown foreign matter in the package.As the device was returned opened, cook was unable to determine where the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed a total of eight nonconforming events which could contribute to this failure mode.All offending nonconformances were for loose foreign matter.These products were reworked, and all remaining devices in the lot underwent quality control activities such as a visual inspection before completion.Additional lots by the same operator were reviewed for complaints related to foreign matter.As of 26feb2019, no additional complaints for foreign matter in a sealed package have been received under these lots.It should also be noted there were no other reported complaints for this specific lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.However, investigation states that a possible cause could be traced to manufacturing and quality control deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Common Device Name: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8264214
• Report Number: 1820334-2019-00142
• Device Sequence Number: 1554958
• Product Code: DRC
• UDI-Device Identifier: 00827002000032
• UDI-Public: (01)00827002000032(17)230612(10)8945174
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: No Information
• Device Expiration Date: 06/12/2023
• Device Model Number: G00003
• Device Catalogue Number: BSDN-18-7.0
• Device Lot Number: 8945174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1