MAUDE Adverse Event Report: COOK INC NEFF PERCUTANEOUS ACCESS SET; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that upon inspection of the received product (august-no other information provided), the affiliate distributor identified a particle inside the packaging of a neff percutaneous access set.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Corrected information: age or date of birth, sex, weight.Investigation: evaluation: a review of the complaint history, device history record, quality control, as well as a visual inspection of the returned device was conducted during the investigation.A visual inspection of the returned device confirmed the presence of two black flakes of unknown material loose within the sealed package.This confirms that the device was not manufactured to specifications.Additionally, a document based investigation evaluation was performed.There are adequate controls in place to ensure the device is manufactured to specifications.A review of the device history record found no relevant nonconformances for this lot.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest 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, a definitive root cause is manufacturing related.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7906954
• Report Number: 1820334-2018-02869
• Device Sequence Number: 1653804
• Product Code: KGZ
• UDI-Device Identifier: 00827002042674
• UDI-Public: (01)00827002042674(17)210714(10)9019365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: No Information
• Device Expiration Date: 07/14/2021
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100
• Device Lot Number: 9019365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1