MAUDE Adverse Event Report: COOK INC VENTRICLEAR DRAINAGE CATHETER SET; NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)

Catalog Number	50318
Medical Device Problem Codes	Flaked (1246); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 residue was visible in the packaging of a cook ventriclear catheter.The device was not used because the customer stated that upon observation, it appeared that "the coating was coming off the device inside the initial packaging." at this point, it is unknown if the residue was the coating of the device or foreign matter.Additional information regarding event details has been requested but is not currently available.No adverse effects have been reported.
Event or Problem Description
Additional information regarding event details was received on 07may2020.The residue was noticed before the device was opened and no patient contact was made.The procedure was completed by using a second ventriclear catheter.The patient was not hospitalized due to this occurrence.
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Correction: d10, h3, h6- device code.H6 - additional method code: (4114) device not returned.Investigation - evaluation.Jennifer thomas from medtronic sofamor danek informed cook on 21apr2020 of an incident involving a ventriclear drainage catheter set [rpn: 50318] from lot number 9323518.On 03jan2020, a device in an unopened package was not used due to visual residue in the packaging.It appeared the coating was coming off the device inside the packaging.A new device was used to complete the procedure.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control, as well as a visual inspection of a photo of the device, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, an image of the device was provided.Upon visual inspection, coating can be seen coming off of the catheter.The device appears to be in unopened and sealed packaging.Cook has concluded that this device was not manufactured to specification.Additionally, a document-based investigation evaluation was conducted.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history records (dhrs) for the reported complaint device lot (9323518) and the related catheter sub-assembly lots revealed one recorded non-conformance related to this failure mode for "coating, abrm in id¿ in which one device was scrapped.A database search found no other events associated with the reported device lot.As cook coats the device with abrm coating, no supplier request was initiated.As there are adequate inspection activities established and objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿ventriclear® ii ventricular drainage catheter set with cook spectrum® antibiotic impregnation¿ provides the following information to the user related to the reported failure mode: precautions.-"inspect contents of this set for damage.If product is damaged, do not use.¿ how supplied.-"store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause has been traced to a deficiency in manufacturing/quality control.The appropriate personnel have been notified.Cook 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.
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: VENTRICLEAR DRAINAGE CATHETER SET
• Common Device Name: NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10028218
• Report Number: 1820334-2020-00913
• Device Sequence Number: 2848297
• Product Code: NHC
• UDI-Device Identifier: 00827002441309
• UDI-Public: (01)00827002441309(17)201113(10)9323518
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2020

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: 11/13/2020
• Device Catalogue Number: 50318
• Device Lot Number: 9323518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 08/06/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/13/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1